Fluid transfer devices and methods of use

ABSTRACT

Some embodiments disclosed herein related to a device for transferring precise amounts of fluid from at least one source container to at least one target container. In some embodiments, the fluid is first transferred from the source container (e.g., a vial) through a connector to an intermediate measuring container (e.g., a syringe). In some embodiments air can pass through an air inlet and enter the vial to compensate for the volume of fluid withdrawn from the vial. An air check valve or a bag or a filter can prevent the fluid from escaping through the air inlet. The precisely measured amount of fluid can then be transferred from the intermediate measuring container to the target container (e.g., an IV bag). In some embodiments the connector can include a source check valve and a target check valve to direct fluid first from the source container to the intermediate measuring container and then from the intermediate measuring container to the target container. Some embodiments of the device can include a motor and a controller for automatically actuating a plunger of the syringe to transfer the desired amount of fluid.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/788,726, filed Oct. 19, 2017, which is a continuation of U.S. patentapplication Ser. No. 15/366,208, filed Dec. 1, 2016, now U.S. Pat. No.9,827,163, which is a continuation of U.S. patent application Ser. No.14/189,920, filed Feb. 25, 2014, now U.S. Pat. No. 9,511,989, which is acontinuation of U.S. patent application Ser. No. 13/937,127, filed Jul.8, 2013, now U.S. Pat. No. 8,973,622, which is a continuation of U.S.patent application Ser. No. 12/845,548, filed Jul. 28, 2010, now U.S.Pat. No. 8,522,832, and entitled FLUID TRANSFER DEVICES AND METHODS OFUSE, which claims the benefit under 35 U.S.C. § 119(e) of U.S.Provisional Patent Application No. 61/229,701, filed Jul. 29, 2009, andentitled FLUID TRANSFER DEVICE, and U.S. Provisional Patent ApplicationNo. 61/354,648, filed Jun. 14, 2010, and entitled FLUID TRANSFER DEVICE.The entire contents of each of the above-identified applications arehereby incorporated by reference herein and made part of thisspecification for all that they disclose.

BACKGROUND OF THE DISCLOSURE Field of the Disclosure

Some embodiments of the invention relate generally to devices andmethods for transferring fluid and specifically to devices and methodfor transferring medical fluids.

Background of the Disclosure

In some circumstances it can be desirable to transfer one or more fluidsbetween containers. In the medical field, it is often desirable todispense fluids in precise amounts and to store and to transportpotentially dangerous fluids. Current fluid transfer devices and methodsin the medical field suffer from various drawbacks, including high cost,low efficiency, intensive labor demands, and excessive fluid or vaporleakage. Some embodiments disclosed herein overcome one or more of thesedisadvantages.

SUMMARY OF SOME EMBODIMENTS

Some embodiments disclosed herein related to devices for transferringprecise amounts of fluid from a source container to a target container.In some embodiments, the fluid is first transferred from the sourcecontainer through a connector to an intermediate measuring container(e.g., a syringe). The precisely measured amount of fluid can then betransferred from the intermediate measuring container to the targetcontainer.

In some embodiments, methods and devices for providing a substantiallyentirely closed system for the transfer of medical fluids between oramong different medical fluid containers include a fluid transfer modulethat can be removably attached to an electronically controlled fluiddispensing system. The fluid transfer module can comprise first andsecond interfaces connected respectively to fluid source and fluiddestination containers. The first and second interfaces can compriseselectively openable and closeable apertures that can substantiallyentirely prevent fluid within the fluid transfer module from escapingthrough the apertures when closed. An intermediate container can be partof or connected to the fluid transfer module. One or more valves withinthe fluid transfer module can permit fluid to move from the fluid sourceto the intermediate container, but can generally obstruct the fluid frommoving from the intermediate container to the fluid source, and canpermit fluid to move from the intermediate container to the fluiddestination, but can generally obstruct the fluid from moving from thefluid destination to the intermediate container. In some embodiments,the fluid transfer module can be attached to an electronicallycontrolled fluid dispensing system, and the fluid transfer module caninclude an interaction portion configured to permit the electronicallycontrolled fluid dispensing system to indicate that at least a portionof the fluid transfer module is attached to the electronicallycontrolled fluid dispensing system. In some embodiments, theelectronically controlled fluid dispensing system can include aninteractive user interface and can be configured to dispense preciseamounts of medical fluid.

BRIEF DESCRIPTION OF THE DRAWINGS

Certain embodiments of the invention will now be discussed in detailwith reference to the following figures. These figures are provided forillustrative purposes only, and the embodiments are not limited to thesubject matter illustrated in the figures.

FIG. 1 schematically shows an embodiment of an automated system fortransferring precise amounts of fluid.

FIG. 2 schematically shows an embodiment of an automated system forcompounding mixtures of precise amounts of fluid.

FIG. 3A is a perspective view of a subsystem for transferring fluid.

FIG. 3B is an exploded perspective view of the subsystem of FIG. 3A.

FIG. 4A is an exploded perspective view of the connector of FIG. 3A.

FIG. 4B is a cross sectional view of the connector of FIG. 4A.

FIG. 5A is a perspective view of the source connector portion of FIG. 4Aadjacent to the vial of FIG. 3A.

FIG. 5B is another perspective view of the source connector portion ofFIG. 4A and the vial of FIG. 3A.

FIG. 5C is a cross-sectional view of the source connector portion andvial of FIG. 5A in engagement.

FIG. 5D is a cross-sectional view of the source connector portion andvial of FIG. 5B in a subsequent stage.

FIG. 6A is a perspective view of the target connector portion of FIG.4A.

FIG. 6B is an exploded perspective view of the target connector portionof FIG. 6A.

FIG. 6C is a top view of a housing portion of the target connectorportion.

FIG. 6D is a cross-sectional view of the target connector portion andthe female connector in an unengaged configuration.

FIG. 6E is a cross-sectional detail view of the target connector portionand the female connector in an engaged configuration.

FIG. 7A is a perspective view of the syringe connector portion of FIG.4A adjacent to the syringe of FIG. 3A.

FIG. 7B is a top view of the syringe connector portion and the syringeof FIG. 7A in engagement.

FIG. 7C is a cross-sectional view of the syringe connector portion andsyringe of FIG. 7A in engagement.

FIG. 8A is a perspective view of the source check valve of FIG. 4B.

FIG. 8B is another perspective view of the source check valve of FIG.8A.

FIG. 9A is an exploded cross sectional view of the source connectorportion and main body of FIG. 4A and the source check valve of FIG. 8A.

FIG. 9B is a cross sectional view of the source connector portion, mainbody, and source check valve shown in FIG. 9A in an assembledconfiguration.

FIG. 10A is a side view of the main body coupled to the source connectorportion of FIG. 4A.

FIG. 10B is a cross sectional view of the source connector portion ofFIG. 4A and the source check valve of FIG. 8A disposed therein.

FIG. 10C is a partial cross-sectional view of the source connector andsource check valve shown in FIG. 10B.

FIG. 10D is a side cross sectional view showing the source connectorportion and the source check valve of FIG. 10B.

FIG. 11 is a side cross sectional view of the source check valve of FIG.10B positioned against a side wall of a chamber.

FIG. 12 is another side cross sectional view of the source check valveof FIG. 10B positioned against a side wall of a chamber.

FIG. 13A is an exploded cross sectional view of the main body, targetconnector portion, and target check valve of FIG. 4B.

FIG. 13B is a cross sectional view of the main body, target connectorportion, and target check valve of FIG. 13A.

FIG. 14A is a cross sectional view of the fluid transfer system of FIG.3A with the source check valve in an open configuration and the targetcheck valve in a closed configuration.

FIG. 14B is a cross sectional view of the fluid transfer system of FIG.3A with the source check valve in a closed configuration and the targetcheck valve in an open configuration.

FIG. 15 is a perspective view of an automated system for transferringfluid having multiple transfer stations.

FIG. 16A is perspective view of a transfer station of the system shownin FIG. 15.

FIG. 16B is a side view of the fluid transfer system shown in FIG. 15.

FIG. 16C is a front view of the transfer station shown in FIG. 16A.

FIG. 17 is a perspective view of the top connector piece of the transferstation shown in FIG. 16A with the top portion thereof removed to show alight source and photodetector disposed therein.

FIG. 18 is a cross sectional view of the syringe and connector of FIG.15 showing regions where the light from the light source of FIG. 17 canintersect the connector.

FIG. 19A is a perspective view of another embodiment of a top connectorpiece.

FIG. 19B is an exploded perspective view of the top connector piece ofFIG. 19A.

FIG. 19C is a side view of a connector for use in transferring fluid.

FIG. 19D is a cross sectional view of the connector of FIG. 19C in whichthe target connector portion is closed.

FIG. 19E is a cross sectional view of the connector of FIG. 19C in whichthe target connector portion is open.

FIG. 20 is a perspective view schematically showing another embodimentof an automated fluid transfer system wherein the system includes asupport bar assembly attached to the housing.

FIG. 21 is a side view of an attachment piece and arm of FIG. 20.

FIG. 22 is a partial perspective view schematically showing anotherembodiment of an automated fluid transfer system wherein one or more ofthe transfer stations include a support arm.

FIG. 22A is a perspective view of a fluid transfer system that includesa support tray for supporting an IV bag.

FIG. 23 is a flowchart that shows an embodiment of a method of operationfor an automated fluid transfer system.

FIG. 24 is a flowchart that shows an embodiment of a method fortransferring fluid.

FIG. 25 is a flowchart that shows an embodiment of a method forconfirming the successful transfer of fluid by checking the IV bagweight.

FIG. 26 is a cross sectional view of another embodiment of a connectorfor transferring fluid.

FIG. 27A is a perspective view of another embodiment of a connector fortransferring fluid.

FIG. 27B is another perspective view of the connector of FIG. 27A.

FIG. 28A is an exploded perspective view of the connector of FIG. 27A.

FIG. 28B is another exploded perspective view of the connector of FIG.27A.

FIG. 29A is a perspective view of a duckbill check valve.

FIG. 29B is another perspective view of the duckbill check valve of FIG.29A.

FIG. 29C is a cross sectional view of the duckbill check valve of FIG.29A in a closed configuration.

FIG. 29D is a cross sectional view of the duckbill check valve of FIG.29A in an open configuration.

FIG. 30A is a perspective view of the connector of FIG. 27A, and asyringe, and a vial in an unassembled configuration.

FIG. 30B is a perspective view of the connector of FIG. 27A, and asyringe, and a vial in an assembled configuration.

FIG. 30C is a front view of the connector of FIG. 27A.

FIG. 31A is a cross sectional view of the connector of FIG. 27A, a vial,and a syringe as fluid is drawn from the vial, through the connector,and into the syringe.

FIG. 31B is a cross sectional view of the connector of FIG. 27A, a vial,and a syringe as fluid is driven from the syringe, through theconnector, and into an IV bag.

FIG. 32A is a perspective view of another embodiment of a connector fortransferring fluid.

FIG. 32B is another perspective view of the connector of FIG. 32A.

FIG. 33A is an exploded perspective view of the connector of FIG. 32A.

FIG. 33B is another exploded perspective view of the connector of FIG.32A.

FIG. 34A is a cross sectional view of the connector of FIG. 32A, a vial,and a syringe as fluid is drawn from the vial, through the connector,and into the syringe.

FIG. 34B is a cross sectional view of the connector of FIG. 32A, a vial,and a syringe as fluid is driven from the syringe, through theconnector, and into an IV bag.

FIG. 35A is a perspective view of another embodiment of a connector fortransferring fluid.

FIG. 35B is another perspective view of the connector of FIG. 35A.

FIG. 36A is an exploded perspective view of the connector of FIG. 35A.

FIG. 36B is another exploded perspective view of the connector of FIG.35A.

FIG. 37 is a perspective view of a check valve assembly that can be usedwith the connector of FIG. 35A.

FIG. 38A is a cross sectional view of the connector of FIG. 35A, a vial,and a syringe as fluid is drawn from the vial, through the connector,and into the syringe.

FIG. 38B is a cross sectional view of the connector of FIG. 35A, a vial,and a syringe as fluid is driven from the syringe, through theconnector, and into an IV bag.

FIG. 39 is a perspective view of a system for transferring preciseamounts of fluid.

FIG. 40 is a perspective view of a fluidics assembly for use with thesystem of FIG. 39.

FIG. 41 is an exploded perspective view of the fluidics assembly of FIG.40.

FIG. 42 is an exploded perspective view of a vial adapter.

FIG. 43 is a cross sectional view of the vial adapter of FIG. 42.

FIG. 44 is a perspective view of a connector of the fluidics assembly ofFIG. 40.

FIG. 45 is another perspective view of the connector of FIG. 44.

FIGS. 46-51 show various views of the connector of FIG. 44.

FIGS. 52-53 are exploded perspective views of the connector of FIG. 44.

FIGS. 54-55 are cross sectional views of the connector and syringe ofthe fluidics assembly of FIG. 40.

FIG. 56 is a perspective view of the IV bag assembly of the fluidicssystem of FIG. 40.

FIG. 57 is an exploded perspective view of an another sample embodimentof an IV bag assembly.

FIG. 58 is a perspective view of a top connector of the system of FIG.39.

FIG. 59 is a perspective exploded view of the top connector of FIG. 58.

FIGS. 60-65 show various views of the top connector of FIG. 58.

FIGS. 66-71 show various views of the cassette of the top connector ofFIG. 58.

FIGS. 72-77 show various views of the base member of the top connectorof FIG. 58.

FIG. 78 is a cross sectional view of the second male connector of theconnector of FIG. 44.

FIGS. 79-81 are perspective views of the top connector that are cut andseparated to illustrate the interior of the top connector.

FIG. 82 is a top-down view of the top connector and syringe of FIG. 81.

FIG. 83 is a side view of a tray attached to the top connector.

FIG. 84 is a side view of the tray and top connector in a disengagedconfiguration.

FIG. 85 is a flowchart showing an embodiment for priming the fluidicsassembly of FIG. 40.

FIG. 86 is a flowchart showing an embodiment for transfer fluid.

FIG. 87 is a flowchart showing an example embodiment for replacing avial during the transfer of fluid.

FIG. 88 is a perspective view of another example embodiment of a systemfor transferring fluid.

FIG. 89 is a perspective view of a top connector from a fluid transferstation of the system of FIG. 88.

FIG. 90 is a perspective view of the tray associated with the topconnector of FIG. 89.

FIG. 91 is a perspective view of the top connector of FIG. 89 with thetray attached thereto in a first configuration.

FIG. 92 is a perspective view of the top connector of FIG. 89 with thetray attached thereto in a second configuration.

FIG. 93 is a split perspective view of the top connector of FIG. 89 andthe tray.

FIG. 94 is a cross sectional view of the top connector of FIG. 89 andthe tray.

FIG. 95 is a perspective view of the cassette from the top connector ofFIG. 89.

FIG. 96 is a front view of the cassette of FIG. 95.

FIG. 97 is a cross sectional view of the connector shown in FIG. 88 withan outline of the cassette from FIG. 95.

FIG. 98 is a perspective view of another example embodiment of aconnector for transferring fluid.

FIGS. 99-104 are cross sectional views of the target connector piecetaken along the line 99-99 of FIG. 97 with the housing positioned asvarious different rotational positions.

FIG. 105 is a side view of another example embodiment of a connectorthat can be used to transfer fluid.

FIG. 106 is a cross sectional view of the target connector portion ofthe connector of FIG. 105.

FIG. 107 is a perspective view of another example embodiment of aconnector that can be used to transfer fluid.

FIG. 108 is a cross sectional view of the target connector portion ofthe connector of FIG. 107 with the valve member in the closed positionand an unobstructed light path.

FIG. 109 is a cross sectional view of the target connector portion ofthe connector of FIG. 107 with the valve member in the open position andan obstructed light path.

FIG. 110 is a cross sectional view of the target connector portion ofthe connector of FIG. 107 with the valve member in the closed positionand an obstructed light path.

FIG. 111 is a cross sectional view of the target connector portion ofthe connector of FIG. 107 with the valve member in the open position andan unobstructed light path.

DETAILED DESCRIPTION OF SOME EXAMPLE EMBODIMENTS

The following detailed description is now directed to certain specificexample embodiments of the disclosure. In this description, reference ismade to the drawings wherein like parts are designated with likenumerals throughout the description and the drawings.

In many circumstances fluid is transferred from a source container to atarget container. In some instances, it can be desirable to transferprecise amounts of a fluid such as a medication into the targetcontainer. For example, in some embodiments a medication can be storedin a vial or other container, and a precise dosage amount of themedication can be extracted and transferred to a target device so thatthe dosage amount can be delivered to a patient. In some embodiments,fluid from multiple source containers can be combined, or compounded,into a single target container. For example, in some embodiments amixture of medications can be created in the target container, or aconcentrated medication can be combined with a diluent in the targetcontainer. To achieve the desired proportions of fluids, it can bedesirable to precisely measure the amounts of fluids transferred intothe target container. Also, precisely measuring the amount of fluidtransferred from the source container to the target container can reducethe amount of fluid wasted (e.g., when more fluid than necessary iswithdrawn from the source container). Reduction of waste is desirablebecause in some instances the fluid being transferred can be expensive.

Some embodiments disclosed herein provide a fluid transfer device fortransferring precise amounts of fluid from one or more source containersinto one or more target containers.

In some embodiments, it can be desirable to transfer fluids from asource container to a target container using a sealed system. In someembodiments, exposing the fluid to ambient air can allow contaminants toenter the fluid or cause an undesirable reaction with the fluid. Somemedications (e.g., chemotherapy medications) can be harmful to a healthyindividual. Therefore, it can be desirable to prevent or reduce exposureof the fluid being transferred to the ambient air or area outside thefluid transfer system. In some embodiments, a fluid transfer system thatprevents or reduces exposure of the fluid to the area outside the fluidtransfer system can render other expensive equipment (e.g., a cleanroom) unnecessary, thereby reducing the cost associated withtransferring the fluids.

Some embodiments disclosed herein provide a fluid transfer device fortransferring fluid while preventing, reducing, or minimizing the amountof contact the fluid has with the ambient air or area outside the fluidtransfer system.

FIG. 1 schematically shows an embodiment of an automated fluid transfersystem 100. The system 100 can include a housing 102 enclosing acontroller 104 and a memory module 106. The system 100 can also includea user interface 108, which can be, for example, external to the housing102. The user interface 108 can also be integrated into the housing 102in some cases. The user interface 108 can include, for example, adisplay, a keypad, and/or a touch screen display. The user interface 108can be configured to receive instructions from the user, for example,regarding the amounts of fluid to be transferred and the types of fluidsto be transferred. The user interface can also be configured to provideinformation to the user, such as error messages, alerts, or instructions(e.g., to replace an empty vial). The system 100 can also include a barcode scanner 110 in communication with the controller 104. Although inthe embodiment shown, the controller 104 and memory module 106 arecontained within the housing 102, a variety of other configurations arepossible. For example, controller 104 can be external to the housing102, and can be, for example contained within a second housing whichalso contains the user interface 108. In some embodiments, the system100 can include a communication interface 105 configured to receiveinformation (e.g., instructions) from a remote source such as a terminalor an automated management system, etc. In some embodiments, thecommunication interface can also send information (e.g., results oralerts) to the remote source. In some embodiments, the system 100 doesnot include a communication interface 105 and does not communicate witha remote source.

The system 100 can include multiple transfer stations 112 a-c. In theembodiment shown, the system 100 includes three transfer stations 112a-c, but a different number of transfer stations can be used. Forexample, in some embodiments, the system may include a single transferstation. In other embodiments, the system may include two, four, five,six, seven, eight, or more transfer stations depending on the number ofdifferent fluid types the system is designed to handle and the amount offluid to be transferred.

Each transfer station 112 a-c can include a fluid source container 114a-c, which can be, for example, a medical vial or other suitablecontainer such as a bag, a bottle, or a vat, etc. Although manyembodiments disclosed herein discuss using a vial as the sourcecontainer, it will be understood the other containers can be used evenwhen not specifically mentioned. In some embodiments, each of the sourcecontainers 114 a-c can contain a unique fluid, providing a variety offluids that the user can select for transfer. In other embodiments, twoor more of the source containers 114 a-c can contain the same fluid. Insome embodiments, the source containers 114 a-c include bar codes thatidentify the types of fluid contained therein. The bar codes can bescanned by the scanner 110 so that the identities of the fluidscontained by source containers 114 a-c can be stored within memorymodule 106. In some embodiments, the fluid transfer stations 112 a-c areconfigured to transfer precise amounts of fluid from source containers114 a-c to target containers 116 a-c, which can be, for example IV bags.It will be understood that in various embodiments described herein, adifferent type of target connector or destination container can be usedinstead of an IV bag (e.g., a syringe, a bottle, a vial, etc.) even whennot specifically mentioned. In some embodiments the fluid can first betransferred from source containers 114 a-c to intermediate measuringcontainers 118 a-c so that a precise amount of fluid can be measured.The intermediate measuring containers 118 a-c can be, for example,syringes. After being measured, the fluid can be transferred fromintermediate measuring containers 118 a-c to the target containers 116a-c. In some embodiments, one or more of the transfer stations 112 a-ccan include one or more pairs of male and female fluid connectorsconfigured to be attached to each other to selectively permit thepassage of fluid. When fluid transfer is completed, the connectors canbe detached or disconnected. In some embodiments, the connectors can beconfigured to automatically close. The fluid module can be removed whileretaining substantially entirely or entirely all of the remaininginterior fluid within the respective connectors and the rest of thefluid module, thus permitting the transfer to occur in a substantiallyentirely or entirely closed system, thereby diminishing the risk ofdamage caused by liquid or vapor leakage from the fluid module afterdisconnection and from the fluid source and the fluid destination afterdisconnection.

In some embodiments, the system 100 can be configured to be compatiblewith a variety of sizes of syringes. For example, larger volume syringescan be used to transfer larger volumes of fluid in shorter amounts oftime. Smaller volume syringes can be used to increase the accuracy andprecision with which amounts of fluid can be transferred. In someembodiments, the syringes can include a bar code which identifies thevolume of the syringe. The bar code can be scanned by a bar code scanner110, so that the sizes of the syringes used by the different transferstations 112 a-c can be stored within memory module 106 for use by thecontroller 104.

In some embodiments, connectors 120 a-c connect the source containers114 a-c, the intermediate containers 118 a-c, and the target containers116 a-c. In some embodiments, the connectors 120 a-c can include firstcheck valves (not shown) configured to allow fluid to flow from thesource containers 114 a-c into the connector 120 a-c, and block fluidfrom flowing connector 120 a-c into the source containers 114 a-c, asshown by single-headed arrows. The connectors 120 a-c can also includesecond check valves (not shown) configured to allow fluid to flow fromconnectors 120 a-c into target containers 116 a-c, but block fluid fromflowing from target containers 116 a-c into connectors 120 a-c, as shownby single-headed arrows. In some embodiments, the connectors 120 a-c canbe in two-way fluid communication with the intermediate containers 118a-c, as shown by double-headed arrows.

In some embodiments, the system 100 can include mounting modules 122 a-cfor mounting the transfer stations 112 a-c onto the housing 102. Forexample, in some embodiments the mounting modules 122 a-c can beconfigured to securely receive intermediate measuring containers 118 a-cas shown in FIG. 1. The system 100 can also include motors 124 a-c,which can be for example, contained within housing 102. The motors 104a-c can be configured to actuate the plungers on the syringes 118 a-c todraw fluid into the syringes and to dispel fluid therefrom. The motors124 a-c can be in communication with the controller 104, and can receiveactuation instructions from the controller 104.

In some embodiments, the system can include fluid detectors 126 a-cconfigured to detect a presence or absence of fluid in connectors 120a-c. The fluid detectors 126 a-c can be in communication with thecontroller 104 so that when the detectors 126 a-c detect an absence offluid in connectors 120 a-c, indicating that source fluid containers 114a-c have run dry, they can send a signal to controller 104 that a sourcecontainer 114 a-c needs to be replaced. The fluid detectors 126 a-c canbe for example an infrared LED and photo detector, or other type ofelectronic eye, as will be discussed in more detail below. In theembodiment shown, fluid detectors 126 a-c are shown connected toconnectors 128 a-c, but other configurations are possible. For example,fluid detectors 126 a-c can be connected to fluid source containers 114a-c themselves.

In some embodiments, the system 100 can include compatibility mechanisms127 a-c for ensuring that an approved connector 120 a-c has been placedin communication with the system 100 to ensure the accuracy of theamount of fluid transferred. The compatibility mechanisms 127 a-c canbe, for example, a specifically shaped mounting feature configured tocorrespond to a portion of the connector 120 a-c.

In some embodiments, the system 100 can include source adapters 129 a-cconfigured to receive the source containers 114 a-c and removablyconnect to the connectors 120 a-c. Thus, when a source container 114 a-cruns out of fluid, the empty source container 114 a-c and itscorresponding adapter 129 a-c can be removed and replaced withoutremoving the associated connector 120 a-c from the system 100. In someembodiments, source adapters 129 a-c can be omitted, and the sourcecontainers 114 a-c can be directly received by the connectors 120 a-c.

In some embodiments the system 100 can include sensors 128 a-c fordetecting the presence of target containers 116 a-c. Sensors 128 a-c canbe in communication with the controller 104 so as to prevent the system100 from attempting to transfer fluid when no target container 116 a-cis connected. A variety of sensor types can be used for sensors 128 a-c.For example, sensors 128 a-c can be weight sensors or infrared sensorsor other form of electronic eye. In some embodiments, weight sensors 128a-c can also be used to measure the weight of the target containers 116a-c after fluid has been transferred. The final weight of a targetcontainer 116 a-c can be compared to an expected weight by thecontroller 104 to confirm that the proper amount of fluid wastransferred into the target container 116 a-c. Sensors 128 a-c can be avariety of other sensor types, for example sensor pads or other sensortypes able to detect the presence of target containers 116 a-c.

FIG. 2 schematically illustrates a system 200 for automated precisetransfer of fluids. System 200 can be the same as or similar to thesystem 100 in some regards. Some features shown in FIG. 1, such as theadapters 129 a-c and compatibility mechanisms 127 a-c, are not shownspecifically in the system 200, but it will be understood that system200 can include corresponding features. The system 200 can include ahousing 202, a controller 204, a memory 206, a user interface 208, ascanner 210, and a communication interface 205, similar to thosedescribe above in connection with the system 100. System 100 isconfigured to transfer individual fluids from the source containers 114a-c to target containers 116 a-c. System 200, on the other hand, isconfigured to transfer and combine fluids from source containers 214 a-cinto a common target container 216. Thus, system 200 can be used forcompounding mixtures of fluids. In some embodiments, a single system canbe configured both for compounding mixtures of fluids and for thetransfer of individual fluids from a single-source container to asingle-target container. For example, a system containing six fluidtransfer stations can be configured so that transfer stations 1-3 arededicated to compounding mixtures of fluids into a single common targetcontainer, while fluid transfer stations 4-6 can be configured to eachtransfer fluid from a single source container to a single targetcontainer. Other configurations are possible. In the embodiment shown inFIG. 2, the system 200 can include sensors 228 a-c for detecting whetheror not the connectors 220 a-c are connected to the common targetcontainer 216. The system 200 can also include a sensor 229 fordetecting the presence of the common target container 216. In someembodiments, the sensor 229 can measure the weight of the common targetcontainer 216 and can report the weight to the controller 104. Thecontroller 104 is then able to compare the final weight of the commontarget container 216 with an expected weight to confirm that the commontarget container 152 was filled with the correct amount of fluids.

FIGS. 3A and 3B show a subsystem, or fluidics assembly, 300 fortransferring precise amounts of fluid from a medical vial 314 to an IVbag 316. FIG. 3A is a perspective view of subsystem 300, and FIG. 3B isan exploded perspective view of subsystem 300. The subsystem 300 caninclude a syringe 318 for measuring precise amounts of fluid to betransferred. In some embodiments, the system includes an IV bag assembly330. The IV bag assembly 330 can include the IV bag 316, a connector332, and a piece of tubing 334 connecting the IV bag 316 to theconnector 332. The connector 332 can be, for example, a female medicalconnector. The connector 332 illustrated in FIGS. 3A-B is a version ofthe Clave® connector manufactured by ICU Medical, Inc., of San Clemente,Calif. Various embodiments of a connector of this type are described inU.S. Pat. No. 5,685,866 (the “'866 patent”), the entirety of which isincorporated herein by reference. The subsystem 300 can also include aconnector 320, for interconnecting the vial 314, the syringe 318, andthe IV bag assembly 330.

Turning now to FIGS. 4A and 4B, FIG. 4A shows an exploded perspectiveview of a fluid transfer module in the form of connector 320, and FIG.4B shows a cross-sectional view of the connector 320. The connector 320can include a first interface or source connector portion 336 configuredto provide fluid communication between the connector 320 and the vial314, a second interface of target connector portion 338 configured toprovide fluid communication between the connector 320 and the IV bagassembly 330, and an intermediate connector portion 340 configured toprovide fluid communication between the connector 320 and the syringe318. The connector can also include a main body 342. In the embodimentshown in FIGS. 4A-B, the intermediate connector portion 340 isintegrally formed as part of the main body 342.

In some embodiments, the connector 320 can be a T-connector. In theembodiment shown, the fluid path leading to the IV bag assembly 330 issubstantially perpendicular to the fluid path between the vial 314 andthe syringe 318. A variety of other configurations are possible. Forexample, the fluid pathways can be arranged to intersect at an obliqueangle.

In some embodiments, the source connector portion 336 includes a femaleconnector portion 344 having a slightly tapered internal surface. Themain body 342 of the connector can have a corresponding male connectorportion 346 having a similarly tapered outer surface. The femaleconnector portion 344 and male connector portion 346 can be configuredsuch that when the male connector portion 346 is fully inserted into thefemale connector portion 344 (i.e., the tapered surfaces preventsfurther insertion), a chamber 348 is defined between the end of the maleconnector portion 346 and the base of the female connector portion 344.The male connector portion 346 can be secured to the female connectorportion 344 by applying a plastic welding adhesive (such asDichloromethane) to the outer surface of the male connector portion 346and/or to the inner surface of the female connector portion 344 beforeinsertion. The Dichloromethane can chemically weld the outer surface ofthe male connector portion 346 to the inner surface of the femaleconnector portion 344. Other methods can be used to connect the maleconnector portion 346 to the female connector portion 344, such as sonicwelding, threading, adhesives, etc. In some embodiments, the connectionbetween the main body 342 and the source connector portion 336 ishermetically sealed, and in some embodiments includes a sealing member(not shown), such as an O-ring, to provide the hermetic seal.

In some embodiments, the target connector portion 338 can be similarlyattached to the main body 342. The main body 342 can include a femaleconnector portion 350 with a tapered inner surface, and the targetconnector portion 338 can include a male connector portion 352 with atapered outer surface. When the male connector portion 352 is insertedfully into the female connector portion 350 (i.e., the tapered surfacesprevent further insertion), a chamber 354 is defined between the end ofthe male connector portion 352 and the base of the female connectorportion 350. The connector portions 350, 352 can be secured to oneanother using Dichloromethane or any of the other methods discussedabove. In some embodiments, the connection between the main body 342 andthe target connector portion 338 is hermetically sealed, and in someembodiments, the connection can include a sealing member.

The connector 320 can include a source check valve 356 disposed insidethe chamber 348. The check valve 356 can be configured to allow fluid toflow from the vial 314 into the connector 320, but block fluid fromflowing from the connector 320 into the vial 314. The connector can alsoinclude a target check valve 358 disposed inside chamber 354. Checkvalve 358 can be configured to allow fluid to flow from the connector320 into the IV bag assembly, but blocks fluid from flowing from the IVbag assembly into the connector 320. The check valves 356, 358 will bediscussed in greater detail below.

The main body 342 can be constructed from a variety of materials. Themain body 342 can be constructed from a rigid material such aspolycarbonate or other polymeric materials. In some embodiments, atleast a portion of the main body 342 can be formed from a substantiallytransparent material as discussed below.

FIG. 5A shows a perspective view of the source connector portion 336 andvial 314 in an unengaged configuration. FIG. 5B is another perspectiveview of the source connector portion 336 and vial 314, also in anunengaged configuration. FIG. 5C is a cross-sectional view of the sourceconnector portion 336 and vial 314 in an engaged configuration. FIG. 5Dis a cross-sectional view of the source connector portion 336 and vial314 after a portion of the fluid has been withdrawn from the vial 314.Although FIGS. 5A-5D shown the source connector portion 336 of theconnector 320 separated from the remainder of the connector 320 forsimplicity, it should be understood that the source connector portion336 can be connected to the remainder of the connector 320 when in use.

With reference now to FIGS. 5A-D, the vial 314 can comprise any suitablecontainer for storing medical fluids, and can be for example a medicalvial such as those produced by Abbott Laboratories of Abbott Park, Ill.In some embodiments, the vial 314 includes a body 357 and a cap 359. Insome instances, the vial 314 can be configured to be hermeticallysealed. The body 357 can comprise a rigid substantially imperviousmaterial such as plastic or glass. In some embodiments the cap 359includes a septum 360 and casing 362. The septum 360 can be made of anelastomeric material capable of deforming in such a way that whenpunctured by an item, it forms a substantially airtight seal around thatitem. For example, in some instances the septum 360 comprises siliconerubber or butyl rubber. The casing 362 can surround the septum 360 andcan be made from any suitable material for sealing the vial 314. In someinstances, the casing 362 comprises a metal that is crimped around theseptum 360 and an end portion of the vial body 357 in order to form anairtight seal between the septum 360 and the vial body 357. In someembodiments, casing 362 can include a substantially flat mountingsurface 364. The vial 314 can include a fluid 366, such as a medicalfluid (e.g., a chemotherapy drug) contained within its internal volume.The vial 314 can also include a relatively small amount of sterilizedair 368 also contained within the internal volume.

The source connector portion 336 can include a piercing member 370 whichcan comprise a sheath 372 and a pointed tip 374. The sheath 372 can becylindrical in shape, or it can be a variety of other suitable shapes.For example, in some embodiments, the sheath 372 can be generallyconical in shape and taper toward the pointed tip 374. The piercingmember 370 can comprise a rigid material such as metal or plastic,suitable for insertion through the septum 360, such as a polycarbonateplastic. In some instances the pointed tip 374 is separable from thesheath 372. In other embodiments, the pointed tip 374 and sheath 372 canbe integrally formed or permanently joined. The pointed tip 374 can beconfigured to facilitate piercing of the septum 360. The sourceconnector portion 336 can also include a cap connector 376 configured tosecure the source connector portion 336 to the vial 314. In someembodiments, the cap connector 376 can include an adhesive 378, such asa double-sided tape, disposed on the surface of the cap connector 376. Aremovable covering 380 (shown partially peeled away in FIG. 5B) can bedisposed over the adhesive 378 until it is ready to be used. The vial314 can be secured to the cap connector 376 by removing the covering 380from the adhesive 378 and pressing the vial 314 down onto the sourceconnector portion 336 so that the piercing member 370 pierces the septum360 and the mounting surface 364 comes into contact with the adhesive378. A variety of other connection types can be used to secure the vial314 to the source connection portion 336 of the connector 220.

In some embodiments, the source connector portion 336 can be configuredto automatically equalize pressure within the vial 314 as fluid 366 iswithdrawn. For example, the source connector portion 336 can be aversion of the Genie® closed vial access device manufactured by ICUMedical, Inc. of San Clemente, Calif. Certain embodiments of closed vialaccess devices of this type are disclosed in U.S. Provisional PatentApplication No. 61/090,561 (the “'561 application”), the entirety ofwhich is herein incorporated by reference. For example, the '561application discloses other methods by which the vial 314 can beconnected to the source connector portion 336.

In some embodiments, the source connection portion 336 can include afluid extraction channel 382. The fluid extraction channel 382 caninclude an upper portion 384 that extends from an extraction aperture383 formed in the side wall of the piercing member 370 through a portionof the piercing member 370. The fluid extraction channel 382 can alsoinclude and a lower portion 386 that extends through the femaleconnection portion 344. In certain embodiments, the lower portion 386can be wider than the upper portion 384, defining a shoulder 388 at thetransition from the lower portion 386 to the upper portion 384.

In some embodiments, the sheath 372 can be hollow defining a regulatorchannel 390 that extends through the sheath 372 and through the capconnector 376 to a regulator aperture 392 formed on a position of thesource connector portion 344 that remains exposed to the ambient airwhen the vial 324 is secured to the source connector portion 336. Insome embodiments, a bag 394 can be enclosed within the regulator channel390. The bag can define an inner volume 395 that is in fluidcommunication with the regulator channel 390. In some embodiments, thebag can include a connection region 396 that forms an airtight seal withthe walls of the regulator channel 390 so that air cannot move past theconnection region 396 unless it enters the inner volume 395 of the bag394. In some embodiments, the connection region 396 of the bag 394 canbe secured to the sheath 372 by an adhesive, or by any other suitablemanner.

The bag 394 can be folded up inside the regulator channel 390 so that itoccupies a relatively small volume compared to its unfolded state. Thebag 394 can be configured to be able to fill all, or a substantialportion, of the internal volume of the vial 314. In some embodiments,the bag 394 can comprise a elastomeric material, such as Mylar®,polyester, polyethylene, polypropylene, saran, latex rubber,polyisoprene, silicone rubber, polyurethane, and latex-free siliconethat can allow the bag 394 to unfold, expand, and/or contract. In someembodiments, the bag 394 can comprise a non-expandable material that isflexible enough to allow the bag to unfold. In some circumstances, thebag 394 can comprise a material that is impervious to liquid and air andinert with respect to the fluid 366.

FIG. 5C illustrates an embodiment of the source connector portion 336coupled to the vial 314 at a stage before any of the fluid 366 isextracted. By comparison, FIG. 5D illustrates an embodiment of thesource connector portion 336 coupled to the vial 314 at a stage with thebag 394 deployed after some of the fluid 366 has been extracted.Although not shown in FIGS. 5C and 5D, the fluid extraction channel 382of the source connector portion 336 can be in fluid communication withthe syringe 318 or other medical instrument capable of creating anegative pressure to extract fluid 366 from the vial 314. In somecircumstances, a volume of the fluid 366 can be withdrawn from the vial314 by the syringe causing the pressure within the vial 314 to drop. Thereduced pressure in the vial can cause the tip 374 to disengage from thesheath 372, so that the bag 394 is free to emerge from the sheath 372.As the fluid 366 flows out of the vial 314 and toward the syringe 318,ambient air flows into the inner volume 395 of the bag 394 by way of theregulator channel 390 and the regulator aperture 392. In somecircumstances the inner volume 395 of the bag 394 expands (by the bagunfolding and/or expanding) to compensate for the reduced pressureinside the vial 314.

Thus, the source connector portion 336 can be configured to allow thefluid 366 to be withdrawn from the vial 314 while regulating thepressure within the vial 314. In some embodiments, the source connectorportion 336 maintains a substantially constant pressure within the vial314 as the fluid 366 is withdrawn therefrom. In some embodiments, thepressure within the vial 314 changes by no more than about 1-5 psi asthe fluid 366 is withdrawn. The '561 application discloses additionaldetails and various alternatives that can be applied to the sourceconnector portion 336 and vial 314.

FIG. 6A shows a perspective view of the target connector portion 388.FIG. 6B is an exploded perspective view of the target connector portion388. FIG. 6C shows a top view of a housing portion of the targetconnector portion 388. FIG. 6D shows a cross-sectional view of thetarget connector portion 388 and the female connector 332 in anunengaged configuration. FIG. 6E shows a cross-sectional view of thetarget portion 338 and the female connector 332 in an engagedconfiguration. Although the target connector portion 338 is shownseparated from the remainder of the connector 320 in FIGS. 6A-6E, itshould be understood that the target connector portion 338 can beconnected to the remainder of the connector 320 when in use.

With reference now to FIGS. 6A-6E, the target connector portion 338 ofthe connector 320 can be a closeable male luer connector that isconfigured to prevent fluid from escaping from or entering into theconnector when it is not engaged with a corresponding female connector,but allow fluid to flow when it is engaged with a corresponding femaleconnector 332. In the embodiments shown, the target connector portion338 can be a version of the Spiros® closeable male connectormanufactured by ICU Medical, Inc., of San Clemente, Calif. Variousembodiments of connectors of this type are described in U.S. PatentPublication No. 2008/0287920 (the “'920 Publication”), the entirety ofwhich is incorporated herein by reference. Although the embodimentsillustrated in FIGS. 6A-6E show the connector 332 as being a femaleconnector and the target connector portion 338 as being a maleconnector, it should be noted that other configurations are possible.For example, the connector 332 can be a male connector while the targetconnector portion 338 can be a female connector. In some embodiments, asubstantially entirely or entirely closed system can be achieved, atleast in part, by providing corresponding automatically closeable maleand female connectors at various (or all) connection points within thefluid transfer system 100, thereby causing the stationary fluid tosubstantially entirely remain within the fluid source, the fluid module,and the fluid target, respectively, upon disconnection and to notgenerally leak or vaporize outside of the system. For example, in someembodiments, corresponding pairs of automatically closing connectors(e.g., male and female connectors) can be provided at the interfacesbetween the fluid source and the fluid module, the fluid module and theintermediate container, and/or the fluid module and the destination ortarget container.

The target connector portion 338 can include a housing 398, a valvemember 400, a resilient member 402, a sealing ring 404, an end cap 406,and an O-ring 407. The housing 398 can be generally tubular in shape,and can include a passageway 408 that extends axially through thehousing. As illustrated, the passageway 408 includes apertures on eachside of the connector. The housing 398 can include a male luer tip 410that connects to the rest of the housing 398 at a base 412. The luer tip410 can be generally tubular in shape so that a portion of thepassageway 408 is defined therein, and the luer tip 410 can include ahole 414 at its end providing access to the passageway 408. In someembodiments, the luer tip 410 includes a shelf 416 that extends radiallyinwardly toward the axis of the passageway 408. The shelf 416 can belocated adjacent to the hole 414, so that the passageway 408 is narrowedat the end of the luer tip 410. In some embodiments, the surface of theshelf 416 that faces radially inwardly is tapered so that the passageway408 is narrowest immediately adjacent to the hole 414. In somecircumstances, the shelf 416 can be configured to seal the passagewaywhen a portion of the valve member 400 is abutted against it. Asillustrated, in some embodiments, connectors can be used tosubstantially entirely prevent fluid therein to leak, vaporize, orotherwise escape through apertures in the fluid pathway when theconnectors are closed.

The luer tip 410 can be surrounded by a shroud 418. In some embodiments,the luer tip 410 extends some distance beyond the edge 420 of theshroud. The shroud 418 can include inner threads 422 on its interiorsurface. The inner threads 422 can be used for securing a femaleconnector 332. The shroud can include an indented portion 424 that has asmaller outer diameter than the other portions of the housing. Theindented portion 424 can be configured to engage a portion of theresilient member 402.

The housing 398 can include two wall sections 426 a, 426 b separated bytwo gaps 428 a, 428 b. The gaps 428 a, 428 b can be configured toreceive portions of the resilient member 402. The wall sections 426 a,426 b can be configured to engage the end cap 406.

In some embodiments, the housing 398 includes a middle portion 430located substantially between the wall sections 426 a, 426 b, andconnected to the wall sections 426 a, 426 b near the gaps 428 a, 428 b.In some embodiments, holes 432 a, 432 b are defined between the middleportion 430 and the wall sections 426 a, 426 b (as shown in FIG. 6C). Insome embodiments, the luer tip 410 connects to the middle portion 430 atits base 412. In some embodiments, the middle portion defines a portionof the passageway 408 therein. In some embodiments, portions 434 of theouter surface of the middle portion 430 are exposed by the gaps 428 a,428 b. The portions 434 can include notches 436 a, 436 b andthrough-holes 438 a, 438 b. The notches 436 a, 436 b can be generallyrectangular in shape, and can be tapered such that the notches 436 a,436 b are narrower near their bases than near their surfaces. Thethrough-holes 438 a, 438 b can also be generally rectangular in shape.

The housing 398 can be constructed from a variety of materials. Thehousing 398 can be constructed from a rigid material such aspolycarbonate or other polymeric materials. In some embodiments, thehousing 398 can be constructed from a hydrophobic material such as BayerMakrolon, or any other suitable material. In some embodiments, thehousing 398 can be formed from a substantially transparent material.

The valve member 400 can include a fluid passageway 440 extendingaxially from an opening formed in a base portion 444 and into a tube446. In some embodiments, the passageway 440 can be wider in the baseportion 444 than in the tube 446. In some embodiments, the tube 446includes a narrowed tip 448. In some embodiments, the tip 448 can have atapered outer surface. The tip 448 can be tapered to substantially thesame degree as the radially inwardly facing surface of the shelf 416 andcan be sized so that the tip 448 can form a fluid seal with the shelf416 when abutted against it. In some embodiments, the tip 448 can bemade from a flexible or compressible material, such as silicone rubberto facilitate formation of the fluid seal between the tip 448 and theshelf 416. In some embodiments, the tube can include one or more holes450 for providing access to the fluid passageway 440. The holes 450 canbe formed, for example, in the tip 448 of the tube 446.

In some embodiments, the valve member 400 can include two struts 452 a,452 b extending out from the base 444 and positioned on either side oftube 446, so that an open space is defined on either side of the tube.In some embodiments, the tube 446 can extend axially past the ends ofthe struts 452 a, 452 b.

The base 444 of the valve member 400 can include a plurality ofprotrusions 454 extending radially outwardly from its external surface.In some embodiments, the protrusions 454 can be positioned so as todefine two channels 456 a, 456 b therebetween. In some embodiments, theprotrusions 454 do not extend across the full length of the base 444,leaving a lower portion 458 of the base 444 that has a substantiallysmooth outer surface.

The valve member 400 can be constructed from a variety of materials,such as polycarbonate or other polymeric materials. In some embodiments,the valve member 400 can be constructed from the same material as thehousing 398. In some embodiments, the valve member 400 and housing 398can be constructed from different materials. In some embodiments, thevalve member 400 can be constructed from multiple materials or frommultiple pieces. For example, the tip 448 can be constructed from amaterial that is more flexible than the remainder of the valve member400. In some embodiments, the valve member 400 can be formed from asubstantially opaque material.

The resilient member 402 can include a first ring 460 and a second ring462 connected to each other by elastic members 464 a, 464 b. The elasticmembers 464 a, 464 b can be made from an elastic material that exerts arestoring force when stretched, such as silicon rubber. Thus, if therings 460, 462 are pulled apart, the elastic members 464 a, 464 bfunction to restore the rings 460, 462 to their relaxed configuration.In some embodiments, the rings 460, 462 are also constructed from anelastic material, such as the same material used to form the elasticmembers 464 a, 464 b. In some embodiments, the second ring 462 can havea greater diameter than the first ring 460. In some embodiments, thesecond ring 462 can have a tapered outer surface so that the end of thesecond ring 462 that is closest to the first ring 460 is wider than theend of the second ring 462 that is furthest from the first ring 460.

The sealing ring 404 can be generally cylindrical in shape, and can havea bore 466 extending axially therethrough. The sealing ring 404 can havea cylindrical body section 468 and an O-ring 470 located at one end ofthe body section 468. In some embodiments, the thickest portion of theO-ring 470 can be thicker than the body section 468 so that the thickestportion of the O-ring 470 extends radially inwardly toward the axis ofthe bore 466 a distance past the inner surface of the body section 468.Thus, the bore 466 can be narrower at the thickest part of the O-ring470 than in the body section 468. In some embodiments, the thickestportion of the O-ring 470 also extends radially outwardly a distancepast the outer surface of the body section 468. The sealing ring 404 caninclude two protrusions 472 a, 472 b that extend radially outwardly fromthe body section 468. In some embodiments, the protrusions 472 a, 472 bcan be generally rectangular in shape.

The sealing ring 404 can be constructed from a variety of materials. Insome embodiments, the sealing ring 404 can be constructed from adeformable or elastic material such as a silicone rubber. In someembodiments, the sealing ring 404 can be constructed from the samematerial used for form the resilient member 402. In some embodiments,the sealing ring 404 can be constructed from a material capable offorming a fluid seal against a rigid plastic or other rigid polymericmaterial.

The end cap 406 can include a first end cap member 405 and a second endcap member 409. The second end cap member 409 can include a maleconnector 352, a plunger 474, and a disk portion 476 located between themale connector 352 and the plunger 474. The second end cap member 409can have a fluid passageway 478 axially positioned therein. In someembodiments, the plunger 474 can be generally tubular in shape. In someembodiments, the outer surface of the plunger 474 includes an indentedregion 480, which can be configured to receive the O-ring 407 therein.The O-ring 407 can be constructed from an elastic material such assilicone rubber so that it can be stretched over the edge 482 of theplunger 474 and be seated in the indented region 480. In someembodiments, the O-ring 407 can be constructed from the same material asthe resilient member 402 and/or the sealing ring 404. In someembodiments, the O-ring 407 can be sized so that when seated in theindented region 480, the thickest portion of the O-ring 407 extendsradially outwardly a distance past the outer surface of the plunger 474.

In some embodiments, the passageway 478 can have a substantiallyconstant width throughout the second end cap member 409. In someembodiments, the passageway 478 can be tapered so that it is wider inthe male connector 352 than in the plunger 474. In some embodiments, thepassageway 478 can narrow near the end of the plunger 474, for example,to accommodate the indented region 480.

The first end cap member 405 can be generally frustoconical in shape andcan have a central opening 471 therein. When assembled, the plunger 474can extend through the central opening 471. A ridge 473 can extendinward into the central opening 471. The ridge 473 can be received intoa channel 475 formed between the base of the plunger 474 and the diskportion 476 on the second end cap member 409 to secure the first end capmember 405 to the second end cap member 409. The ridge 473 andcorresponding channel 475 can allow the first end cap member 405 torotate about a longitudinal axis with respect to the second end capmember 409. Thus, the first end cap member 405 and the second end capmember 409 can join to form the end cap 406.

The valve end cap 406 can be constructed from a variety of materials,such as polycarbonate or other rigid polymeric materials. In someembodiments, the end cap 406 can be constructed from the same materialas the housing 398 and/or the valve member 400.

In some embodiments, the end cap 406 can be constructed from a differentmaterial than the valve member 400 and/or the housing 398. The first endcap member 405 can be formed from the same material as the second endcap member 409, or different materials can be used. In some embodiments,the first end cap member 405 or the second end cap member 409 or bothcan be substantially transparent.

Certain interconnections between various parts of the target connectorportion 338 will now be discussed in further detail. The sealing ring404 can be positioned inside the middle portion 430 of the housing 398.The protrusions 472 a, 472 b can be sized and positioned so that theyengage the through-holes 438 a, 438 b. Thus, the sealing ring 404 can besecured to the housing 398 so that it does not rotate or move axiallywith respect to the tube 446.

The valve member 400 can be slidably inserted into the housing 398 sothat the tube 446 enters the passageway 408. The narrowed tip 448 of thetube 446 can pass through the bore 466 of the sealing ring 404 and intothe male luer tip 410 until it abuts against the shelf 416. The tube 446can have a width that substantially fills the bore 446 and pressesagainst the O-ring 470 portion of the sealing ring 404 to form a fluidseal therebetween. The struts 452 a, 452 b can pass through the holes432 a, 432 b in the housing 398 respectively, so that the struts 452 a,452 b are positioned between the male luer tip 410 and the shroud 418.

The resilient member 402 can function to bias the valve member 400against the housing 398. The first ring 460 can fit onto the lowerportion 458 of the base 444 of the valve member 400, so that a surfaceof the ring 460 abuts against the protrusions 454. The second ring 462can fit into the indented portion 424 of the housing. The elasticmembers 464 a, 464 b can be positioned in the channels 456 a, 456 brespectively, and can pass through the respective gaps 428 a, 428 bbetween the wall sections 426 a, 426 b of the housing 398.

The O-ring 407 can be seated onto the indented region 480 of the end cap406, as discussed above, and the plunger 474 can be slidably inserted atleast partially into the passageway 440 of the valve member. In someembodiments, the thickest portion of the O-ring 407 can be wider thanthe portion of the passageway 440 formed in the base 444 of the valvemember 400, so that the O-ring 407 forms a fluid seal against the innersurface of the passageway 440. The plunger 474 can be inserted into thevalve member 400 until the disk portion 476 of the end cap 406 comesinto contact with the ends of the wall sections 426 a, 426 b of thehousing 398.

In some embodiments, the wall sections 426 a, 426 b can be secured tothe top surface 477 of the first end cap member 405 by sonic welding,snap fit structures (not shown), a pressure or friction fitting, orother suitable connection type. As mentioned above, the first end capmember 405 can be secured to the second end cap member 409 in a mannerthat allows the first end cap member 405 to rotate relative to thesecond end cap member 409. Thus, once the target connector portion 338is assembled, the housing 398, sealing ring 404, resilient member 402,valve member 400, and first end cap member 405 can rotate relative tothe second end cap member 409 about the longitudinal axis.

With reference now to FIGS. 6D-6E, the target connector portion 338 canbe configured to engage a female connector 332. A variety of types offemale connectors 332 can be used. The female connector 332 shown is aclosable female luer connector that includes a housing 490, a spike 492,a base 494, and a resilient seal element 496. A fluid passageway 498 canpass through the base 494 and through the spike 492. The spike 492 caninclude one or more holes 500 providing fluid communication between thepassageway 498 and the area outside the spike 492. The seal element 496can be shaped and positioned to substantially surround the spike 492.The seal element 496 can include a closable aperture 502 or slit thatcan open to allow the tip of the spike 492 to pass through then end ofthe seal element 496 when the seal element 496 is compressed (as shownin FIG. 6E). The housing can include external threads 504 configured toengage the inner threads 422 on the housing 398 of the target connectorportion 338. An end of the tubing 334 can be connected to the end of thefemale connector 332 by an adhesive, clamp, friction or pressurefitting, or other suitable manner to form a fluid tight connection.

As discussed above, in some embodiments, the housing 398, sealing ring404, resilient member 402, valve member 400, and first end cap member405 can rotate about the longitudinal axis with respect to the secondend cap member 409. Thus, as the female connector 332 of the IV bagassembly is attached to the target connector portion 338, the femaleconnector 332 can be held still while the housing 398 of the targetconnector portion 338 can rotate causing the threads 504, 422 to engage.Because the female connector 322 is not required to rotate duringengagement and disengagement with the target connector portion 338, thetubing 334 can avoid being twisted or kinked and the user is notrequired to twist the IV Bag to accommodate rotation of the femaleconnector 322. Embodiments of the connectors with this rotationalcapability are disclosed in greater detail in the '920 Publicationincorporated by reference herein in its entirety.

When not engaged with the female connector 332 (as shown in FIG. 6D),the target connector portion 338 can be sealed. In some embodiments,fluid can enter the target connector portion 338 at the male connector352 and pass through the passageway 478 of the end cap 406, through thepassageway 440 of the valve member 400, through the holes 450, and intothe portion of the passageway 408 defined by the male luer tip 410. Butthe fluid seal created by the tip 448 of the valve member 400 pressingagainst the shelf 416 of the male luer tip 410 prevents the fluid fromexiting the target connector portion 338. In some embodiments, anincrease in pressure, such as when additional fluid is forced into thetarget connector portion 338, causes the tip 448 to press more firmlyagainst the shelf 416, thereby improving the fluid seal.

When the target connector portion 338 is engaged with the femaleconnector 332 (as shown in FIG. 6E), the external threads 504 of thefemale luer connector 332 can engage the inner threads 422 on the shroud418, securing the female connector 332 to the target connector portion338. The edge of the male luer tip 410 can press against and compressthe resilient seal element 496 so that the spike 492 passes through theaperture 502 until the holes 500 are exposed. The end of the housing 490of the female luer connector 332 can enter the space between the maleluer tip 410 and the shroud 418 until it contacts the struts 452 a, 452b. As the female luer connector 332 further engages the target connectorportion 338, it can push on the struts 452 a, 452 b causing the entirevalve member 400 to retract. As the valve member 400 retracts, theelastic members 464 a, 464 b of the resilient member 402 stretch. Whenthe valve member 400 retracts, the tip 448 disengages from the shelf416, breaking the fluid seal and allowing fluid pass from the passageway408 in the housing 398 of the target connector portion 338 to thepassageway 498 in the female connector 332 via the holes 500. Whenengaged, the resilient seal element 496 exerts a restoring force towardthe target connector portion 338 that presses the end of the sealelement 496 against the end of the male luer tip 410, forming a fluidseal therebetween. Thus, the fluid can be kept isolated from theexternal environment while it is transferred from the target connectorportion 338 to the female connector 332.

The female connector 332 can be disengaged from the target connectorportion 338. The restoring force exerted by the resilient seal element496 of the female connector 332 causes it to return to its closedposition, sealing off its passageway 498. The elastic members 464 a, 464b of the resilient member 402 exert a restoring force on the valvemember 400, causing the valve member 400 to return to its closedposition with its tip 448 abutted against the shelf 416 as the femaleconnector 332 is disengaged.

The '920 Publication discloses additional details and variousalternatives that can be applied to the target connector portion 338 ofthe connector 320.

FIG. 7A shows a perspective view of the syringe 318 and the intermediateconnector portion 340 of the connector 320 in an unengagedconfiguration. FIG. 7B is a top view of the syringe 318 and intermediateconnector portion in an engaged configuration. FIG. 7C is across-sectional view of the syringe 318 and intermediate connectorportion 340 in an engaged configuration. Although FIGS. 7A-7C show themain body 342 of the connector 320 separated from the remainder of theconnector 320 for simplicity, it should be understood that the main body342 can be connected to the remainder of the connector 320 when in use.

In the embodiment shown, the intermediate connector portion 340 is anintegral part of the main body 342 of the connector 320. Otherconfigurations are possible. For example, in some embodiments, theintermediate connector portion 340 can a separate piece connected to themain body 342. The intermediate connector portion 340 can include afemale connector 506. In some embodiments, the female connector 506 canhave a tapered inner surface. The external surface of the femaleconnector 506 can include external threads 508.

The syringe 318 can have a hollow syringe body 510 defining an internalvolume 511. The syringe can include a male luer tip 512 at one end and ashroud 514 surrounding the male luer tip 512. The shroud 514 can haveinternal threads 516. The male luer tip 512 and threaded shroud 514 canbe configured to securely mate with the female connector 506 on theintermediate connector portion 340 of the connector 320, forming a fluidtight connection therebetween. The syringe body 510 can include a bodyflange 518 positioned at the end of the body opposite the male luer tip512. The syringe also includes a plunger 520 that can be slidablyreceived into the internal volume of the syringe body 510. The plunger522 can include a stopper 522 or other sealing member configured to forma fluid tight seal against the inner surface of the syringe body 510. Aplunger flange 524 can be positioned on the plunger 520 at the endopposite the stopper 522.

In some embodiments, the female connector 506 and the male luer tip 512can be open to the atmosphere when unengaged. Other configurations arepossible. For example, in some embodiments, the female connector 506 canbe a sealing female connector similar to the female connector 332described above, and can be for example a version of the Clave®connector. Similarly, the syringe 318 can include a sealing maleconnector, or a sealing male connector can be connected between thesyringe 318 and the female connector 506. In some embodiments thesealing male connector can be a version of the Spiros™ connector. Thus,in some embodiments, the fluid in the syringe 318 and in the connector320 can be isolated from the environment even when they are disengagedfrom each other.

In some embodiments, when the syringe 318 is engaged with the connector320 (as shown in FIG. 7B) the internal volume 511 of the syringe 318 canbe in two way fluid communication with the connector 320. Thus, as theplunger 520 is retracted a fluid can be drawn from the connector 320into the internal volume 511 of the syringe 318. Then as the plunger 520is advanced the fluid can be directed out of the internal volume 511 andinto the connector 320.

As discussed briefly above, the connector 320 can include a source checkvalve 356 and a target check valve 358. The check valves 356, 358 canfunction so that when the plunger 520 is retracted the source checkvalve 356 opens and the target check valve 358 closes, allowing fluid toflow from the vial 314 through the connector 320 and into the syringe318. Then, when the plunger 520 is advanced the source check valve 356can close and the target check valve 358 can open, allowing fluid toflow from the syringe 318 through the connector 320 and into the IV bag316.

FIG. 8A is a perspective view showing the source check valve 356.

FIG. 8B is another perspective view showing the source check valve 356from a different angle. The source check valve 356 can include a diskshaped base 526. A plurality of feet 528 can extend axially from oneside of the base 526. In the embodiment shown, the source check valve356 includes four feet 528, but other numbers of feet 528 can be used,such as three feet, or five feet, or another suitable number of feet528. In some embodiments, the feet 528 can each be generally cylindricalin shape and can each include a rounded tip 530. Other shapes andconfigurations are possible. The source check valve 356 can have asealing surface 531 located on the side opposite the feet 528.

FIG. 9A shows the source connector portion 336, the source check valve356, and the main body 342 in an exploded cross-sectional view. FIG. 9Bis a cross-sectional view of the source connector portion 336, thesource check valve 356, and the main body 342 in an assembledconfiguration with the check valve 356 in an open position. As discussedabove, the source connector portion 336 can include a fluid extractionchannel 382 having an upper, narrow portion 384 and a lower, wideportion 386. A shoulder 388 can be defined at the transition from theupper portion 384 to the lower portion 386 of the fluid extractionchannel 382. In some embodiments, the lower portion 386 of theextraction channel 382 can have a tapered inner surface, so that thelower portion 386 narrows near the shoulder 388. The upper portion 384can also have a tapered inner surface, so that the upper portion 384widens near the shoulder 388. In some embodiments, the upper portion 384and/or the lower portion 386 can be substantially cylindrical or canassume a variety of other shapes having a substantially uniformcross-sectional area.

The main body 342 can include a first fluid passageway 532 leading fromthe end 534 of the male connector 346 to the end 534 of the intermediateconnector portion 340. The first fluid passageway 532 can include anupper portion 536 and a lower portion 538. The lower portion 538 can bewider than the upper portion 536 defining a shoulder 540. The upperportion 536 and lower portion 538 can have tapered or untapered innersurfaces. When assembled, the source check valve 356 can be positionedin the chamber 348 located between the end 534 of the male connector 346and the shoulder 388 of the fluid extraction channel 382. The sourcecheck valve 356 can be positioned so that the feet 528 face toward theend 534 of the male connector 346, while the sealing surface 531 canface toward the shoulder 388. In some configurations, when the pressurein the fluid passageway 332 is sufficiently higher than the pressure inthe extraction channel 382, such as when the plunger 520 of the syringe318 is advanced forcing fluid into the fluid passageway 332, the sourcecheck valve 356 is pushed away from the main body 342 and the sealingsurface 531 engages the shoulder 388 forming a fluid tight seal thatprevents fluid from flowing from the first fluid passageway 532 into theupper portion 384 of the extraction channel 382. In some configurations,when the pressure in the fluid passageway 332 is sufficiently lower thanthe pressure in the extraction channel 382, such as when the plunger 520of the syringe 318 is retracted drawing fluid out of the fluidpassageway 332, the source check valve 356 is pulled away from theshoulder 388 and the feet 528 rest against the end 534 of the maleconnector 346 in an open position.

FIG. 10A is a side view of the main body 342 coupled to the sourceconnector portion 336 of the connector 320. FIG. 10B is a crosssectional view of the source connector portion 336 of the connector 320and the source check valve 356 disposed therein. FIG. 10C is a partialcross-sectional view showing the source check valve 356 positioned in achamber 348 defined radially by the walls of the female connector 344.FIG. 10D is another cross sectional view showing the source check valve356 positioned in the chamber 348.

With reference to FIGS. 10A-10D, the base 526 of the source check valve356 can be disk shaped and can have a diameter d₁ that is less than thediameter d₂ of the chamber 438, defining a space 542 between the sideedges of the source check valve 356 and the inner walls of the chamber348 through which fluid can pass. Also, the feet 528 can be spaced sothat open areas 544 are defined between adjacent feet 528.

Thus, when the source check valve 356 is in the open position, fluid canflow from the upper portion 384 of the extraction channel 382, into thechamber 348, through the space 542 between the side edges of the sourcecheck valve 356 and the inner walls of the chamber 348, through the openareas 544 between the feet 528, and into the upper portion 536 of thefirst fluid passageway 532.

In some embodiments, the source check valve 356 can be configured toallow a substantially open flow around the check valve 356 withoutsignificant bottlenecking. For example, the space 542 between the sideedges of the source check valve 356 and the inner walls of the chamber348 can have a cross-sectional area A₁ that is at least large as thecross-sectional area A₂ of the upper portion 483 of the extractionchannel 382 taken near the chamber 348. This relationship can beexpressed as equation (1) below.

A ₁ ≥A ₂  (1)

In some embodiments, the chamber 348 and the source check valve 356 canboth be substantially cylindrical, having diameters d₂ and d₁respectively (as shown in FIGS. 10C and 10D). The cross sectional areaA₁ of the space the space 542 between the side edges of the source checkvalve 356 and the inner walls of the chamber 348 can then be defined byequation (2) below.

A ₁=π(d ₂/2)²−π(d ₁/2)²  (2)

In some embodiments, the upper portion 483 of the extraction channel 382taken near the chamber 348 can be substantially cylindrical and can havea diameter d₃ (as shown in FIG. 10D). The area A₂ can then be defined byequation (3) below.

A ₂=π(d ₃/2)²  (3)

By substituting equations (2) and (3), equation (1) can be rewritten asequation (4) below.

π(d ₂/2)²−π(d ₁/2)²≥π(d ₃/2)²  (4)

By solving equation (4) for d₁, equation (4) can be rewritten asequation (5) below.

d ₁≤√{square root over (d ₂ ² −d ₃ ²)}  (5)

Thus, when the diameter d₂ of the chamber 348 and the diameter d₃ of theupper portion 483 of the extraction channel 382 are known, the sourcecheck valve 356 can be having a diameter that satisfies equation (5) toavoid bottlenecking of fluid as it flows through the space 542.

As shown in FIG. 10D, in some embodiments, when the source check valve356 is in the open position a space 546 having a height h₁ is definedbetween the sealing surface 531 and the shoulder 388. The space 546 canallow fluid to flow therethrough. In some embodiments, the source checkvalve 356 and the chamber 348 can be configured to prevent bottleneckingas fluid flows through the space 546. For example, in the embodimentshown, the smallest area of the space 546 through which the fluid flowscan be described as an open an imaginary open cylinder (shown by dottedlines in FIG. 10D) having a height of h₁, a diameter of d₃, and asurface area A₃. If the surface area A₃ of the imaginary cylinder is atleast as great as the cross-sectional area A₂ of the upper portion 483of the extraction channel 382 taken near the chamber 348, bottleneckingcan be reduced. This relationship can be expressed as equation (6)below.

A ₃ ≥A ₂  (6)

The surface area A₃ of the imaginary open cylinder can be expressed asequation (7) below.

A ₃ =πd ₃ h ₁  (7)

By substituting equations (3) and (7), equation (6) can be rewritten asequation (8) below.

πd ₃ h ₁≥π(d ₃/2)²  (8)

By solving for h₁, equation (8) can be rewritten as equation (9) below.

h ₁ ≥d ₃/4  (9)

Thus, when the diameter d₃ of the upper portion 483 of the extractionchannel 382 is known, the source check valve 356 can be made to have atotal height that is shorter than the height of the chamber 348 by atleast d₃/4 to reduce bottlenecking as the fluid flows from the upperportion 483 of the extraction channel 382 into the space 546 between thesource check valve 356 and the shoulder 388.

The source check valve 356 can be configured to reduce bottlenecking ofthe fluid as it flows through the open areas 544 (shown in FIG. 10C)between the feet 528. For example, if the total area A₄ of the openareas 544 between the feet 528 is at least as great as thecross-sectional area A₂ of the upper portion 483 of the extractionchannel 382 taken near the chamber 348, bottlenecking can be reduced asthe fluid flows from the extraction channel 382 and around the checkvalve 356. This relationship can be expressed by equation (10) below.

A ₄ ≥A ₂  (10)

In the embodiment shown, the feet 528 are arranged so that an imaginaryopen cylinder (shown by a dotted line in FIG. 10C) can be placed so thatits edge intersects each of the feet 528. The feet 528 can be positionedso that the imaginary cylinder has a diameter d₄. In some embodiments,the source check valve 356 includes a number n of feet that each havesubstantially equal diameters d₅ and substantially equal heights h₂. Thearea total area A₄ of the open areas 544 can be defined by equation (11)below. It should be noted that because the feet 528 have rounded tips530, the area A₄ can be slightly greater than represented by equation(11). In some embodiments, the feet 528 do not have rounded tips and canbe substantially cylindrical.

A ₄ =πd ₄ h ₂ −nd ₅  (11)

By substituting equations (3) and (11), equation (10) can be rewrittenas equation (12) below.

πd ₄ h ₂ −nd ₅≥π(d ₃/2)²  (12)

By using feet 528 that satisfy equation (12), bottlenecking can bereduced. For example, if the number n of feed or the diameter d₅ isincreased, the height h₂ of the feet can be increased, or the feet canbe moved closer to the peripheral edge (increasing d₄) to compensate.

In some embodiments, the source check valve 356 can be configured toprovide a substantially uniform flow of fluid. For example, the space542 between the side edges of the source check valve 356 and the innerwalls of the chamber 348 can have a cross-sectional area A₁ that issubstantially equal to the cross-sectional area A₂ of the upper portion483 of the extraction channel 382 taken near the chamber 348. Similarly,the surface area A₃ of the first imaginary cylinder can be substantiallyequal to the cross-sectional area A₂ of the upper portion 483 of theextraction channel 382 taken near the chamber 348. Likewise, the totalarea A₄ of the open areas 544 between the feet 528 can be substantiallyequal to the cross-sectional area A₂ of the upper portion 483 of theextraction channel 382 taken near the chamber 348. The source checkvalve 356 and chamber 348 can be configured so that other areas of flowalso have an area that is substantially equal to the cross-sectionalarea A₂ of the upper portion 483 of the extraction channel 382 takennear the chamber 348. For example, in some embodiments, the shoulder 388or the sealing surface 531 of the check valve 356 can be tapered so thatthe height of the space 546 is smaller near the side space 542 than nearthe upper portion 483 of the extraction channel 382. In someembodiments, the areas discussed herein can be considered to besubstantially equal if they vary by an amount less than an acceptabletolerance T. In some embodiments, the acceptable tolerance T can be lessthan about 1 mm, 0.5 mm, 0.1 mm, 0.05 mm, or 0.01 mm. In someembodiments, the flow areas around the check valve 356 (e.g., A₁, A₃,and A₄) can be smaller than A₂ by an amount no larger than tolerance T.Thus, in some embodiments, a small but acceptable amount ofbottlenecking can occur as the fluid flows around the source check valve356.

In embodiments where the diameter d₂ of the chamber 348 is greater thanthe diameter d₁ of the source check valve 356, the source check valve356 can move not only axially within the chamber, but also radiallywithin the chamber. For example, FIG. 11 shows a cross-sectional view ofthe source check valve 356 positioned against one side of the chamber348 when in a closed position. The diameter d₁ of the check valve 356can be large enough to allow the check valve 356 to adequately seal offthe chamber 348 when positioned against one side of the chamber 348. Forexample, in some embodiments, the chamber 348 can be generallysymmetrical so that the shoulder 388 has a substantially uniform width,and the diameter d₁ of the check valve 356 can be chosen to satisfy theequation (13) below.

$\begin{matrix}{d_{1} > {\frac{d_{2}}{2} + \frac{d_{3}}{2}}} & (13)\end{matrix}$

In some embodiments, the upper portion 536 of the first fluid passageway532 can be generally cylindrical in shape and can have a diameter d₆. Insome embodiments, the feet 528 are positioned near enough to theperipheral edges of the check valve 356 so the feet do not drop into theupper portion 536 of the first fluid passageway 532 when the check valve356 is positioned against the side of the chamber 348. For example, FIG.12 shows a cross-sectional view of the source check valve 356 positionedagainst one side of the chamber 348 in an open position. The feet 528are positioned so that when the check valve 356 is positioned againstone side of the chamber 348 the foot 528 a closest to the firstpassageway 532 does not drop down into the first passageway 532. In someembodiments, the feet 528 can be positioned along a circle concentricwith the check valve 356, the circle having a diameter d₄ that satisfiesthe equation (14) below.

d ₄ ≥d ₆ +d ₂ −d ₁  (14)

In some embodiments, the source check valve 356 can have a diameter ofabout 2 mm to about 20 mm, although diameters outside this range canalso be used. A variety of other configurations are possible. Forexample, the source check valve 356, the chamber 348, the extractionchannel 382 and/or the first fluid passageway 532 can have non-circularcross sections.

Turning now to FIGS. 13A-B, FIG. 13A shows an exploded cross-sectionalview of the target connector portion 338, the target check valve 358,and the main body 342. FIG. 13B shows a cross-sectional view of thetarget connector portion 338, the target check valve 358, and the mainbody 342 in an assembled configuration with the target check valve 358in an open position. The main body 342 can include a second fluidpassageway 548 that intersects the first fluid passageway 532 at ajunction 550. In some embodiments, the second fluid passageway 548 canintersect the upper portion 536 of the first fluid passageway 532. Inthe embodiment shown the second fluid passageway 548 intersects thefirst fluid passageway 532 at a substantially right angle. Otherconfigurations are also possible. For example, the fluid passageways532, 548 can intersect at an oblique angle. The second fluid passageway548 can have a narrow portion 552 and a wide portion 554 that define ashoulder 556. In some embodiments, the narrow portion 552 can have awidth that is substantially the same as the width of the upper portion536 of the first fluid passageway 532 near the junction 550, while inother embodiments the narrow portion 552 can have a width that issmaller or larger than the width of the upper portion 536 of the firstfluid passageway 532 near the junction 550. In some embodiments, thenarrow portion 552 and/or the wide portion 554 of the second fluidpassageway 548 can have tapered interior surfaces. For example, the wideportion 554 can be tapered so as to receive a tapered male connector352, as discussed above.

When assembled, the target check valve 358 can be positioned in thechamber 354 formed between the male connector 352 and the shoulder 556.In some embodiments, the target check valve 358 can be similar to thesource check valve 356 described above, having a disk shaped base 558, aplurality of feet 560, and a sealing surface 562. The target check valve358 can be positioned with the feet 560 facing the male connector 352and the sealing surface 562 facing the shoulder 556. Thus, when thepressure in the second fluid passageway 548 is sufficiently higher thanthe pressure inside the male connector 352, such as when the plunger 520of the syringe 318 is advanced forcing fluid into the main body 342, thetarget check valve 358 can be pushed toward the male connector 352 sothat the feet 560 rest against the end of the male connector 352 in anopen position. When the pressure in the second fluid passageway 548 issufficiently lower than the pressure inside the male connector 352, suchas when the plunger 520 of the syringe 318 is retracted drawing fluidout of the main body 342, the target check valve 358 can be pulled awayfrom the main body 342 so that the sealing surface 562 engages theshoulder 556 forming a fluid tight seal that prevents fluid from flowingfrom the chamber 354 into the narrow portion 552 of the second fluidchannel 548.

In some embodiments, the target check valve 358 and the chamber 354 canbe configured to reduce bottlenecking as fluid flows around the targetcheck valve 358 in its open position. For example, the target checkvalve 358 and chamber 354 can be configured similarly in many ways tothe source check valve 358 and chamber 348 described above.

The check valves 356, 358 can work together to direct fluid through thesystem. FIG. 14A shows the flow of fluid (by flow lines) as the plunger520 is retracted. Fluid is drawn out of the vial 314 through the upperportion 384 of the fluid extraction channel 382. The fluid flows intothe chamber 348 and around the source check valve 356, which is in theopen position. The fluid flows through the first fluid passageway 532and into the syringe 318. The fluid can enter the narrow portion 552 ofthe second fluid passageway 548, but the target check valve 358 is inthe closed position and prevents the fluid from entering the chamber354.

FIG. 14B shows the flow of fluid (by flow lines) as the plunger 520 isadvanced. Fluid is expelled from the syringe 318, into the first fluidpassageway 532, through the narrow portion 552 of the second fluidpassageway 548, into the chamber 354, around the target check valve 358(which is in the open position), through the target connector portion338, toward the IV bag 316. The fluid can travel up the first fluidpassageway 532 and into the chamber 348, but the source check valve 356is in the closed position and prevents the fluid from advancing backinto the vial 314. In some embodiments, the force of the fluid pressingagainst the source check valve 356 is strong enough the overcome theforce of gravity pulling the source check valve 356 downward so as tomaintain the source check valve 356 in the closed position.

The check valves 356, 358 can be formed from rigid, semi-rigid, ordeformable materials. In some embodiments, at least the sealing surfaces531, 562 of the check valves 356, 358 can be formed from a materialcapable of forming a fluid tight seal against a plastic or other rigidmaterial. In some embodiments, the check valves can include asilicon-based deformable material, or a rubber. In some embodiments, thefeet 528, 560 can be formed from different material than the disk shapedbase 526, 558. In some embodiments, the feet 528, 560 can be formed froma rigid polycarbonate or other polymeric material.

FIG. 15 is a perspective view of an automated system 600 fortransferring fluid, which can be similar to or the same as the otherautomated fluid transfer systems (e.g., 100, 200) disclosed herein. Thesystem 600 can include a base housing 602, and six transfer stations 604a-f, located on a front side of the base housing 602. In someembodiments, the system 600 can include a different number of transferstations 604 a-f (e.g., one, two, four, five, eight, or more transferstations). In some embodiments, the transfer stations 604 a-f can bedistributed on multiple sides of the base housing 602. Transfer stations604 b-f are shown in an empty state having no syringe attached thereto.Transfer station 604 a is shown having a syringe 606 and a connector 608attached thereto. During operation, a vial (not shown) can be attachedto the top of the connector 608 and an IV bag (not shown) can be placedin fluid connection with the connector 608 so that fluid can betransferred from the vial to the syringe 606 and then from the syringe606 into the IV bag, as discussed above. Also, during operation, some orall of the transfer stations 604 a-f can be equipped similarly totransfer station 604 a. In some embodiments, multiple transfer stations604 a-f can operate simultaneously. In some embodiments, multipletransfer stations 604 a-f can be placed in fluid communication with asingle IV bag so that fluid from multiple vials can be combined into asingle IV bag. In some embodiments, one or more of the transfer stations604 a-f can include a dedicated IV bag so that fluid from only a singletransfer stations can be transferred into the dedicated IV bag.

Turning now to FIGS. 16A-16C, and 17, a transfer station 604 a is shownin greater detail. FIG. 16A shows a partial perspective view of thetransfer station 604 a, with the syringe 606 and connector 608 in anunengaged configuration. FIG. 16B shows a left-side view of the transferstation 604 a, with the syringe 606 and connector 608 in an unengagedconfiguration. FIG. 16C shows a front-side view of the transfer station604 a, with the syringe 606 and connector 608 omitted from view. Thetransfer station 604 a can include an auxiliary housing 610 connected tothe base housing 602. The transfer station 604 a can also include a topconnector piece 612 attached to the base housing 602 above the auxiliaryhousing 610, and a bottom connector piece 614 attached to the basehousing 602 below the auxiliary housing 610. The top connector piece 612and the bottom connector piece 614 can extend out a distance past theauxiliary housing 610, and a pair of shafts 616 a-b can extendvertically between the top connector piece 612 and the bottom connectorpiece 614. A middle connector piece 618 can be attached to the shafts616 a-b.

The middle connector piece 618 can have a recess 620 configured toreceive the syringe body 624. For example, if the syringe body 624 isgenerally cylindrical, the recess 620 can in the shape of a halfcylinder (as shown). The middle connector piece 618 can also include aslit 622 configured to receive the body flange 626 of the syringe 606.The top connector piece 612 can have a recess 628 configured to receivethe shroud 630 of the syringe 606 and a portion of the connector 608. Insome embodiments, the middle connector piece 618 can be removable, sothat it can be interchanged with additional middle pieces (not shown) toprovide compatibility with different sizes and shapes of syringes. Also,in some embodiments, the position of the middle connector piece 618 canbe adjustable. For example, the middle connector piece 618 can be slidup and down the shafts 616 a-b and secured in a variety of location,providing compatibility with syringes of different lengths. In someembodiments, the position of the middle connector piece 618 can befixed.

The transfer station 604 a can include an actuator 632 configured toretract and advance the plunger 634 of the syringe 606. In theembodiment shown, the actuator 632 includes an actuator base 636. Twoshafts 648 a-b can be positioned at the back of the actuator base 636and can extend upward from the actuator base 636 into the auxiliaryhousing 610. Another shaft 640 can be positioned at the front of theactuator base 636 and can extend upward in front of the auxiliaryhousing 610. An end piece 642 can be attached to the end of the shaft640 opposite the actuator base 636. The end piece 642 can include ahorizontal slit 644 configured to receive the plunger flange 648 of thesyringe 606. The end piece 642 can also be configured to receive aportion of the plunger shaft 650 that is near the plunger flange 648.For example, if the plunger shaft 650 includes four longitudinal ribs(as shown), the end piece 642 can include a vertical slit 646 configuredto receive one of the longitudinal ribs. The end piece 642 can alsoinclude a thumb screw 652 which can be tightened to apply pressure tothe plunger flange 648 and prevent the syringe 606 from accidentallydisengaging from the transfer station 604 a.

In some embodiments, a motor (not shown) is located inside the auxiliaryhousing 610. The motor can be an electric motor, a pneumatic motor, ahydraulic motor, or other suitable type of motor capable of moving theactuator 632. In some embodiments, the motor can be a piston type motor.In some embodiments, the motor is contained within the base housing 602rather than in the auxiliary housing 610. In some embodiments, eachtransfer station 604 a-f has an individual motor dedicated to theindividual transfer station 604 a-f. In some embodiments, one or more ofthe transfer stations 604 a-f share a motor, and in some embodiments,the system 600 includes a single motor used to drive all the transferstations 604 a-f. The motor can drive the shafts 638 a-b downward out ofthe auxiliary housing 610, which in turn drives the rest of the actuator632 downward causing the plunger 634 to retract from the syringe body624 to draw fluid into the syringe. The motor can also draw the shafts638 a-b upward into the auxiliary housing 610, which in turn drives therest of the actuator 632 upward causing the plunger 632 to advance intothe syringe body 624 to expel fluid from the syringe.

In some embodiments, the transfer station 604 a can include a label 654that uniquely identifies the specific transfer station 604 a. In someembodiments the label 654 can be prominently displayed at the top of thetransfer station 604 a. The label 654 can be colored, and each of thetransfer stations 604 a-f can have a different colored label.

The system 600 can include a controller, for controlling the operationsof the transfer stations 604 a-f. The controller can start and stop themotor(s) of the system 600 to control the amount of fluid that istransferred from the vial to the IV bag at each transfer station 604a-f. The controller can be one or more microprocessors or other suitabletype of controller. The controller can be a general purpose computerprocessor or a special purpose processor specially designed to controlthe functions of the system 600. The controller can include, or be incommunication with, a memory module that includes a software algorithmfor controlling the operations of the system 600. The controller can becontained within the base housing 602. In some embodiments, thecontroller can be external to the base housing 602, and can be forexample the processor of a general purpose computer that is in wired orwireless communication with components of the system 600.

In some embodiments, the transfer station 604 a includes a sensor(hidden from view in FIGS. 16A-C) configured to determine when theliquid in the vial (not shown) has run out. If the plunger 634 isretracted to draw fluid into the syringe 606 when the vial contains nomore fluid, air is drawn out of the vial and travels into the connector608 toward the syringe. Air may also be drawn into the connector 608when the vial still contains a small amount of fluid, but the fluidlevel is low enough that air is drawn out of the vial along with thefluid (e.g., as an air bubble). In some embodiments, the sensor candetect air in the connector 608. For example, the sensor can be aninfrared light source (e.g., an LED) and a photodetector, or other formof electric eye.

In some embodiments, the sensor can be located inside the top connectorpiece 612. The top connector piece 612 can be made from a bottom portion656 and a top portion 658. FIG. 17 shows a perspective view of thebottom portion 656 of the top connector piece 612, with the top portion658 removed. The bottom portion 656 can include a central cavity 660 anda pair of grooves 662 a-b, one on either side of the recess 628. Grooves664 a-b can connect the grooves 662 a-b to the central cavity 660. Insome embodiments, the grooves 662 a-b, 664 a-b can have semi-circularcross sections. In other embodiments, the grooves can be V-grooves, orany other suitably shaped grooves. The grooves 662 a-b can be open atthe ends furthest from the recess 628. In some embodiments, the grooves662 a-b can also be open at the ends closest to the recess 628. In someembodiments, walls 665 a-b can separate the grooves 662 a-b from therecess 628, except that the walls 665 a-b can have holes 666 a-b thatconnect the grooves 662 a-b to the recess 628.

A light source 668 can be located in the groove 662 a, and aphotodetector 670 can be located in the groove 662 b. In someembodiments, the light source 668 can be a laser light source that isaligned to direct a laser beam of light through the hole 666 a, acrossthe recess 628, into the hole 666 b, and onto the photodetector 670. Insome embodiments, the light source 668 can be an LED or other type oflight source. In some embodiments, the light source 668, can emit lightin many directions, so that some of the light passes through the hole666 a, across the recess 628, into the hole 666 b, and onto thephotodetector 670. A wire 672 can be connected to the light source 668and can run along the groove 664 a and through the central cavity 660.The wire 672 can provide power or other electric signals from thecontroller to the light source 668. A wire 674 can be connected to thephotodetector 670 and can run along the groove 664 b and through thecentral cavity 660. The wire 674 can carry electric signals from thephotodetector 670 to the controller.

In some embodiments, the top portion 658 (not shown in FIG. 17) of thetop connector piece 612 can have grooves and/or cavities that correspondto the grooves and/or cavities formed in the bottom portion 656. In someembodiments, the top portion 658 can have a generally flat underside soas to act as a lid to the grooves and/or cavities that are formed in thebottom portion 656. The top portion 658 can be attached to the bottomportion 656 by an adhesive, a clamp, snap or friction fit structures, orvarious other manners known in the art or yet to be devised. In someembodiments, the top portion 658 is removably attached to the bottomportion 656 so that the user can access the light source 668 andphotodetector 670 for calibration, repair, replacement, etc.

When the syringe 606 and connector 608 are attached to the transferstation 604 a, the connector 608 (not shown in FIG. 17) can bepositioned in the path of light 676 traveling from the light source 668to the photodetector 670. In some embodiments, the at least a portion ofthe connector 608 can be made from a substantially transparent plasticor other suitably material that allows the light 676 to pass through thewalls of the connector 608. FIG. 18 is a side-view of the syringe 606and connector 608 and illustrates the location on the connector 608 thatintersects the light 676. In some embodiments, the connector 608 can bepositioned so that the light 676 passes through the connector 608 at alocation that is below the lower end of the source connector portion677, but above the male luer tip 678 of the syringe 606. This area ismarked as region 680 in FIG. 18. In some embodiments, the connector 608can be positioned so that light 676 passes through the connector 608above the external shoulder 682 of the connector 608 (shown as region684). In some embodiments, the connector 608 can be positioned so thatlight 676 passes through the first fluid passageway 686 at a locationabove the junction to the second fluid passageway 688 (shown as region690). In some embodiments, the light 676 passes through the connector608 near the midpoint between the lower end of the source connectorportion 677 and the top of the junction, so that turbulence created asfluid flows in and out of the second fluid passageway 688 does notcauses errors in the sensor's readings. In some embodiments, the light676 passes through the connector 608 at a location that is far enoughfrom the male luer tip 678 of the syringe 606 so that when air isdetected as fluid is being drawn into the syringe 606, the flow can bestopped before the air reaches the male luer tip 678.

In some embodiments, the beam of light 676 travelling from the lightsource 668 to the photodetector 670 is large enough to coversubstantially the entire width of the first fluid passageway 686, sothat an air bubble cannot travel down into the syringe 606 withoutcrossing the beam of light 676. In some embodiments, the holes 666 a-bshown in FIG. 17 can be larger than as shown, or they can be horizontalslits that allow light to intersect substantially the entire width ofthe first fluid passageway 686.

The light source 668 and photodetector 670 can be configured to detectthe presence of air using absorption spectroscopy, emissionspectroscopy, scattering spectroscopy, fluorescence spectroscopy, orother suitable manner of distinguishing between the presence of air andthe presence of fluid in the path of the beam of light 676.

FIG. 19A is a perspective view of another embodiment of a top connectorpiece 1900 which can be similar in some regards to the top connectorpiece 612 described above. FIG. 19B is an exploded view of the topconnector piece. The top connector piece 1900 can be used in place ofthe top connector piece 612 in connection with the automated fluidtransfer system 600. For example, the top connector piece 1900 can beconnected to the base housing 602 and can function to receive a portionof the syringe 606 or a portion of the connector 608.

The top connector piece 1900 can include a base member 1902 and acassette 1904. In some embodiments, the base member 1902 can be made ofmetal, such as aluminum, although other materials can be used. Thecassette 1904 can be made from plastic, although other materials can beused. The cassette 1904 can include a bore 1906 configured to align witha bore 1908 formed in the base member 1902 such that the cassette 1904can be secured to the base member 1902 by inserting a bolt, screw, orother fastener through the bores 1906, 1908. In some embodiments, one orboth of the bores 1906, 1908 can be threaded to mate with correspondingthreads on the bolt or other fastener. The bore 1906 can include awidened upper portion to receive the head of the bolt therein. Thecassette 1904 can also be secured to the base member 1902 by a snap-fit,or friction-fit, or in any other suitable manner.

The base member 1902 can include a cutout region 1910 configured toreceive the cassette 1904 such that the top surface of the cassettealigns substantially flush with the top surface of the base member 1902.One or more bores 1912 a-c can extend from the back surface of the basemember 1902 to the cutout region 1910. In the illustrated embodimentthree bores 1912 a-c are shown, although it will be understood thatother numbers of bores can be used. The outer bores 1912 a, 1912 c canreceive pins or other fasteners used to secure the base member 1902 tothe housing 602 of the fluid transfer system 600. The inner bore 1912 bcan provide a channel that allows wires 1914 a-b, 1916 a-b to pass fromthe cutout region 1910 through the base member 1902 and to the housing602. Many other configurations are possible. For example, a single borecan be used for securing the base member 1902 to the housing 602 and forproviding a channel for the wires 1914 a-b, 1916 a-b.

A first light source 1918 a and a corresponding first photodetector 1920a can be positioned inside the top connector piece 1900. The first lightsource 1918 a and first photodetector 1920 a can be similar to the lightsource 668 and photodetector 760 discussed above. Although the firstlight source 1918 a and first photodetector 1920 a are located in thecutout region 1910 in FIG. 19B, it will be understood that the firstlight source 1918 a and first photodetector 1920 a can be positionedinside of the slots 1922 a-b formed in the cassette 1904. The firstlight source 1918 a can be configured to direct light 1924 through ahole 1926 a formed in the cassette 1902, across a recess 1928 a, througha second hole 1926 b formed in the cassette 1902 on the other side ofthe recess 1928 a, and to the first photodetector 1920 a. The wire 1914a can provide power or other electric signals from the controller to thefirst light source 1918 a. A wire 1916 a can carry electric signals fromthe first photodetector 1920 a to the controller.

The first light source 1918 a and first photodetector 1920 a can beconfigured to detect air in the connector 608 similar to the lightsource 668 and photodetector 760 discussed above. The recess 1928 a,1928 b can be configured to receive the syringe 606 and/or connector 608such that a transparent portion of the connector 608 is positioned inthe path of the light 1924 such that the light 1924 passes through aportion of the fluid pathway between the vial and the syringe 606 (e.g.,as discussed above in connection with FIG. 18). The first light source1918 a and first photodetector 1920 a can be configured to detect air inthe fluid pathway and provide a signal to the controller indicating thatthe vial may need to be replaced.

The portion of the recess 1928 a formed by the cassette can besubstantially semicircular in shape to conform to the portion of theconnector 608 configured to assign therewith. The portion of the recess1928 b formed by the base member 1902 can be further enclosed than theportion of the recess 1928 a formed by the cassette, such that a step1930 is formed on either side of the recess 1928 b. The steps 1930 canfacilitate the proper securing and alignment of the connector 608 withthe top connector piece 1900.

A second light source 1918 b and a corresponding second photodetector1920 b can be positioned inside the top connector piece 1900. The secondlight source 1918 b and second photodetector 1920 b can be similar tothe light source 668 and photodetector 760 discussed above. Although thesecond light source 1918 b and second photodetector 1920 b are locatedin the cutout region 1910 in FIG. 19B, it will be understood that thesecond light source 1918 b and second photodetector 1920 b can bepositioned inside of the slots 1922 a-b formed in the cassette 1904. Thecassette 1904 can have a pair of arms 1934 a-b that extend outwardly,and the slots 1922 a-b can extend along the arms 1934 a-b. The basemember 1902 can have corresponding arms 1936 a-b positioned under thearms 1934 a-b of the cassette 1904. The second light source 1918 b canbe configured to direct light 1938 through a hole 1932 a formed in afirst arm 1934 a of the cassette 1902, across a gap formed between thearms 1934 a-b, through a second hole 1932 b formed in the second arm1934 b of the cassette 1902, and to the second photodetector 1920 b. Thewire 1914 b can provide power or other electric signals from thecontroller to the second light source 1918 b. A wire 1916 b can carryelectric signals from the second photodetector 1920 b to the controller.

In some embodiments, the cassette 1904 can be removable from the basemember 1902, providing access to the light sources 1918 a-b,photodetectors 1920 a-b, and wires 1914 a-b, 1916 a-b for repair orreplacement. In some embodiments, the light sources 1918 a-b and/orphotodetectors 1920 a-b can be secured to the cassette 1904 and thecassette 1904 can be interchanged with a replacement cassette if a lightsource 1918 a-b or photodetector 1920 a-b breaks or if differentfunctionality (e.g., a different wavelength of light) is desired.

The second light source 1918 b and the second photodetector 1920 b canbe configured to determine whether an IV bag assembly is connected tothe connector 608. In some embodiments, the controller can be configuredto abort a command from a user to transfer fluid to an IV bag for aparticular transfer station if the controller determines that no IV bagis attached to the particular transfer station, thereby preventing wasteof the fluid to be transferred and preventing exposure to potentiallyhazardous fluids. The controller can also display an error message oralert on the user interface when a command is aborted in this fashion.It should be understood that in some embodiments, a portion of theconnector 608 (e.g., target connector portion 338) can be closed when noIV bag assembly is attached thereto, so that the connector can preventfluid from escaping when no IV bag assembly is attached. However, if thefluid transfer station is permitted to infuse fluid into the closedconnector, high pressure can build up in the connector which cancompromise the closed seal of the connector allowing fluid to escape, orcan cause damage to the system 600. The second light source 1918 b andthe second photodetector 1920 b are one example of a sensor configuredto determine whether an IV bag assembly is attached to the connector608, and it will be understood that other sensor types (e.g., weightsensors) can also be used for detecting the presence of the IV bagassembly.

The manner in which the second light source 1918 b and the secondphotodetector 1920 b detect the presence of an IV bag assembly will bedescribed in connection with FIGS. 19C-E. FIG. 19C is a side view of aconnector 1950 which can be similar to the connector 320 or any otherconnector described herein. The connector 1950 can include a sourceconnector portion 1952 and a target connector portion 1954. In theillustrated embodiment, the source connector portion 1952 and the targetconnector portion 1954 can be attached to a main body piece 1956 whichcan have an intermediate connector portion 1958 configured to receive asyringe or other intermediate measuring container.

FIG. 19D is a cross sectional view of the connector 1950 that shows thetarget connector portion 1954 in a closed state. FIG. 19E is a crosssectional view of the connector 1950 that shows the target connectorportion 1954 in an open state. The target connector portion 1954 can besimilar to the target connector portion 338 described herein. The targetconnector portion 1954 can include a housing 1960 and an end cap 1962that includes an elongate plunger 1964. A valve member 1966 can beslidably engaged with the plunger 1964 such that when the valve is inthe closed position, as shown in FIG. 19D, the base 1968 of the valvemember 1966 overlaps only the end of the plunger 1964, leaving at leasta portion of the plunger 1964 exposed. When the connector 1965 of the IVbag assembly is attached to the target connector portion 1954 (e.g., asdescribed in connection with FIGS. 6D-E), the valve member 1966 isdisplaced toward the end cap 1962 as shown in FIG. 19E.

The second light source 1918 b and the second photodetector 1920 b areshown schematically in FIGS. 19D-E. In some embodiments, at least aportion of the housing 1960 and at least a portion of the plunger 1964can be made of a material that is transparent to the light 1938 emittedby the second light source 1918 b, while the valve member 1966 can bemade of a material that is opaque to the light 1938, or otherwiseprevents the light 1938 from reaching the second photodetector 1920 bwhen placed in the path of the light 1938. Thus, when no IV bag assemblyis attached to the connector 1950 and the target connector portion 1954is in the closed configuration (as shown in FIG. 19D), the light 1938can pass through the transparent housing 1960, through the transparentplunger 1964, and to the second photodetector 1920 b. When the secondphotodetector 1920 b detects the light 1938 it can send a signal to thesystem controller indicating that no IV bag assembly is attached to thetarget connector portion 1954. When the connector of an IV bag assemblyis attached to the target connector portion 1954 the base 1958 of thevalve member 1966 can intersect the path of the light 1938 and preventthe light 1938 from reaching the second photodetector 1920 b, as shownin FIG. 19E. When the second photodetector 1920 b does not detect light1938, it can send a signal to the system controller indicating thattarget connector portion 1954 is in the open configuration and an IV bagassembly is attached thereto.

In some embodiments, the connector 1950 can be aligned so that the light1938 passes through the open space 1970 next to the plunger 1964 withoutintersecting the plunger 1964. Thus, in some embodiments, the plunger1964 can be made of a material that not transparent to the light 1938.In the open configuration, as shown in FIG. 19E, the base 1968 of thevalve member 1966 fills the space 1970 adjacent to the plunger 1964 toblock the light 1938. Thus, in some embodiments, the light 1938 does notpass through the fluid flow path 1972 formed through the targetconnector portion 1954, which can be advantageous in certaincircumstances such as when a fluid is transported through the connectorthat would prevent the light 1938 from reaching the second photodetector1920 b.

FIGS. 19D-E also illustrate the light 1924 emitted by the first lightsource 1918 a being transmitted through the fluid flow path 1974 formedbetween the vial and the syringe to the first photodetector 1920 a, asdescribed above.

Returning now to FIG. 15, the system 600 can include a user interface692 for receiving information and commands from the user and forproviding information to the user. The user interface 692 can be part ofan external unit 694, or it can be integrated into or attached to thebase housing 602. The user interface 692 can include, for example, atouch screen display. The user interface 692 can be in wired or wirelesscommunication with the controller. In some embodiments, a cable 696connects the external unit 694 to the base housing 602 and provides acommunication link between the user interface 692 and the controller. Insome embodiments, the controller can be contained in the external unit694 along with the user interface 692 and the controller can send andreceive signals to and from components (e.g., the motors) of the system600 through the cable 696. The user interface 692 can be configured toreceive instructions from the user regarding the amounts of fluids to betransferred by the transfer stations 604 a-604 f. The user interface 692can deliver the instructions to the controller to be stored in a memoryand/or used to actuate the motor(s) to transfer the desired amount offluids.

In some embodiments, the system 600 can include a communicationinterface (shown schematically in FIG. 15 as antenna 691). Thecommunication interface 691 can be configured to provide a communicationlink between the controller and a remote source, such as a remoteterminal or an automated management system. The communication link canbe provided by a wireless signal or a cable or combination of the two.The communication link can make use of a network such as a WAN, LAN, orthe internet. In some embodiments, the communication interface can beconfigured to receive input (e.g., fluid transfer commands) from theremote source and can provide information (e.g., results or alerts) fromthe controller to the remote source. In some embodiments, the remotesource can be an automated management system which can coordinateactions between multiple automated fluid transfer systems (e.g., 100,200, and 600).

The system 600 can also include a bar code scanner 698, in communicationwith the controller and/or memory. The bar code scanner 698 can be usedto provide information about the system 600 to the controller and/or thememory. For example, the syringe 606 can include a bar code thatidentifies the size and type of the syringe 606. The user can scan thesyringe 606 with the bar code scanner 698 and then scan a bar codeassociated with the transfer station 604 a to inform the controller ofthe size of the syringe 606 that is attached to the transfer station 604a. Different sizes of syringes can hold different volumes of fluid whentheir plungers are withdrawn by the same distance. Thus, when thecontroller is tasked with filling the syringe 606 with a predeterminedamount of fluid, the controller can determine how far the plunger is tobe withdrawn to fill the particular type of syringe with thepredetermined amount of fluid. The vials (not shown) can also includebar codes that indicate the type of fluid contained therein. The usercan scan a vial and then scan the bar code associated with theparticular transfer station the vial is to be installed onto. Thus, thecontroller can be aware of what fluids are controlled by which transferstations to facilitate automated transfer of fluids. Other components ofthe system 600 can also include bar codes readable by the bar codescanner 698 for providing information about the components to thecontroller and/or memory. In some embodiments, the user interface 692can be configured to allow the user to input data relating to the sizeof the syringe 606, the type of fluid contained in a vial, etc. insteadof using the bar code scanner 698.

FIG. 20 is a perspective view that schematically shows anotherembodiment of an automated fluid transfer system 2000. Some aspects ofthe automated fluid transfer system 2000 can be similar to or the sameas the other automated fluid transfer systems (e.g., 100, 200, and 600)described above. The automated fluid transfer system 600 can include abase housing 2002, and six transfer stations 2004 a-f (although thesystem 600 can have other numbers of transfer stations). In FIG. 20, thetransfer stations 2004 a-f are shown schematically as boxes, but itshould be understood that each of the transfer stations 2004 a-f caninclude structure similar to or the same as that described above inconnection with the transfer station 604 a. For example, each transferstation can include a fluid transfer subsystem (e.g., subsystem 300 or1900) including a vial, a syringe, and an IV bag assembly.

The automated fluid transfer system 2000 can include a support barassembly 2050. FIG. 21 is a side view schematically showing a portion ofthe support bar assembly. With reference now to FIGS. 20 and 21, thesupport bar assembly 2050 can include a substantially horizontal supportbar 2052, supported on either side by an arm 2054. Each arm 2054 can beattached to the side of the base housing 2002 by an attachment piece2056. In some embodiments the attachment piece can be integrally formedwith the base housing 2002 or secured thereto, for example, by anadhesive or by one or more screws 2055 or other fasteners. The arm 2054can be attached to the attachment piece 2056 by a shoulder bolt 2058, sothat the arm 2054 can pivot on the shoulder bolt 2058. The rotationalrange of the arm 2054 can be limited by an upper dowel pin 2060 and alower dowel pin 2062. A spring plunger 2064 can be positioned on the arm2054 and can be configured to slide into one or more locking holes(hidden from view in FIGS. 20 and 21) to lock the arm 2054, and thesupport bar 2052, in position. The spring plunger 1064 can be pulled outof the locking hole to release the arm 2054 from the locked position. InFIGS. 20 and 21, the arms 2054 and support bar 2052 are shown locked inan upward position with the arm 2054 positioned adjacent to the upperdowel 2060. The support bar 2052 can be configured to hold or otherwisesupport at least a portion of the one or more fluid transfer subsystemsof the fluid transfer stations 2004 a-f. For example, when locked in theupward position, the support bar 2052 can be positioned so that thetarget connector portion, the female connector attached to the targetconnector portion, the IV bag, or other portion of the IV bag assemblycan rest on the support bar 2052 to reduce the amount of stress placedon the connector.

FIG. 22 is a partial perspective view that schematically shows anotherembodiment of an automated fluid transfer system 2200 that, in someregards, can be the same as or similar to the other automated fluidtransfer systems (e.g., 100, 200, 600, and 2000) disclosed herein. Insome embodiments, one or more of the transfer stations (e.g., 2204 a)can include a support arm 2250. The support arm 2250 can be integrallyformed with or attached to the top connector piece 2212. Alternatively,the support arm 2250 can be separate from the top connector piece 2212and can be secured, for example, directly to the base housing 2202 byone or more screws or other fasteners. In some embodiments, the supportarm 2250 can be substantially “L” shaped, having an elongate extensionportion 2252 and a support platform 2254. The support platform 2254 canbe configured to hold or otherwise support at least a portion of thefluid transfer subsystems of the fluid transfer station 2204 a. Forexample, the support platform 2254 can be positioned so that the targetconnector portion 2236, the female connector (not shown in FIG. 22)attached to the target connector portion 2236, the IV bag (not shown inFIG. 22), or other portion of the IV bag assembly can rest on thesupport platform 2254 to reduce the amount of stress placed on theconnector.

In some embodiments, the support arm 2250 can include a weight sensor2256, or other type of sensor, capable of determining whether an IV bagassembly (not shown in FIG. 22) is connected to the target connectorportion 2236. For example, the weight sensor 2256 can “feel” the weightof the IV bag as the support arm 2250 provides support thereto. Theweight sensor 2256 can be in electronic communication with thecontroller so that the controller can confirm that an IV bag assembly isattached to the target connector portion 2236 before transferring fluidinto the IV bag.

In some embodiments, the weight sensor 2256 can be used to confirm thatthe correct amount of fluid was transferred to the IV bag. Thecontroller can be configured to calculate an expected weight for the IVbag from the instructions received from the user and from informationstored in a memory, e.g., the amount of fluid to be transferred, thedensity of the fluid to be transferred, the starting weight of the emptyIV bag, etc. Once the transfer of fluid is complete the controller canmeasure the final weight of the IV bag using the weight sensor and cancompare the final weight to the expected weight. If the final weightdiffers from the expected weight by more than an acceptable toleranceamount (e.g., determined by the accuracy of the weight sensor), thecontroller can send an error message or alert to the user interfaceinforming the user that an error likely occurred in the fluid transfer(e.g., the wrong fluid type was transferred or the wrong amount of fluidwas transferred).

FIG. 22A is a partial perspective view of another embodiment of anautomated fluid transfer system 2270 that, in some regards, can be thesame as or similar to the other automated fluid transfer systems (e.g.,100, 200, 600, 2000, and 2200) disclosed herein. The system 2270 caninclude a tray 2272 extending out from the housing 2274. The tray 2272can be configured to support the IV bag 2276. The tray 2272 can haveflat base 2278 and sides 2280 a-b that turn up (e.g., by about 30° toabout 60°) to prevent the IV bag 2276 from sliding off the side of thetray 2272. The end 2282 of the tray 2272 furthest from the housing 2274can be open, having no turned up side, so that the IV bag can hang overthe edge of the tray 2272. A support foot 2279 can extend from the baseof the housing 2274 to prevent the system 2270 from tipping forwardunder the weight of the IV bag 2276.

The tray 2272 can include a hole or cutout 2284 configured to align withthe target connector portion 2286 of the connector (which can be similarto the connector 320 or any other connector disclosed herein). In someembodiments, the outer housing 2288 of the target connector portion 2286can rotate relative to the connector 2290 (which can be similar to thefemale connector 322) of the IV bag assembly. Because at least a portionof the target connector portion 2286 is rotatable, the connector 2290 isnot required to rotate when it is attached or detached to the targetconnector portion 2286, so that the tubing 2292 is not twisted or kinkedand the IV bag 2276 need not be twisted. In some embodiments, the targetconnector portion 2286 can rotate to engage the connector 2290 in amanner similar to that described above in connection with FIGS. 6D-E,although it will be understood that any rotating connector can be used.The hole or cutout 2284 formed in the tray 2272 can be configured toallow a user's hand to pass though therethrough when rotating thehousing 2288 of the target connector portion 2286.

The tray 2272 can be removably secured to the housing 2274. In someembodiments, the tray 2272 can be bolted, screwed, or otherwise fastenedto the housing 2274. A snap fit connection or a friction-fit connectioncan also be used. In some embodiments, the end of the tray can fitbetween the top connector piece 2294 and the auxiliary housing 2296 ofthe transfer station with which the tray 2272 is associated. Theembodiment illustrated in FIG. 22A shows a single tray 2272 attached toa transfer station of the system 2270, but it will be understood that aplurality of individual trays can be used, each tray being associatedwith one of the transfer stations. In some embodiments, a single traycan be used for more than one or all the transfer stations.

FIG. 23 is a flowchart that schematically shows a method 2300 ofoperation for an automated fluid transfer system (e.g., 100, 200, 600,2000, and 2200). At block 2302, the system receives a fluid transfercommand. The fluid transfer command can be received, for example, via auser interface from inputs provided by a user, or via a communicationinterface from a remote terminal or an automated management system. Thefluid transfer command can include information such as a fluid type tobe transferred, an amount of the fluid to be transferred, and a desiredconcentration of the fluid. In some embodiments, a fluid transfercommand can include information for multiple fluids to be combined intoa compounded mixture.

At block 2304, the controller determines whether the fluid transferstations of the system are currently equipped to transfer the requestedfluids. In some embodiments, the system includes a memory that includes,for example, a database or lookup table so that the controller candetermine the type of fluids associated with each transfer station. Ifthe fluid transfer stations do not have the specified fluid, the methodcan proceed to block 2306 wherein the user interface can prompt the userto change the fluid(s) of the fluid transfer station(s). In someembodiments, the controller can determine a recommended fluid to replace(e.g., using a history of usage stored in the memory) and provide therecommendation to the user via the user interface. After the user makesthe changes to the fluid transfer station(s), the method 2300 can returnto block 2304 to confirm that the transfer station(s) are properlyequipped.

In some embodiments, the user can specify one or more transfer stationsto use for the fluid transfer, rather than specifying the types offluids desired. Thus in some embodiments, blocks 2304 and 2306 can beomitted. In some embodiments, the user interface can display to the userthe types of fluids associated with the different transfer stations toaid the user in selecting the transfer stations to use for the fluidtransfer.

In some embodiments, the system can contain concentrated fluids in thesource containers and in some circumstances the fluids are to be dilutedwith a diluent prior to delivery to the patient. Therefore, in someinstances, the controller can determine a desired amount of diluentbased upon the concentration of the fluid in the source container, thedesired concentration, and the amount of fluid to be transferred. Theuser interface can prompt the user to fill the target IV bag with thedesired amount diluent. Alternatively one or more of the transferstations of the system can include diluents. Thus, in some embodiments,the controller will determine whether transfer stations are equippedwith the desired medication and the desired diluent.

If the fluid transfer stations are properly equipped, the method 2300can proceed to block 2308 where the controller determines whether the IVbag assembly is properly attached. In some embodiments, the system caninclude, for example, a weight sensor or IR sensor capable ofdetermining whether the target connector portion for a transfer stationis connected to an IV bag assembly. In some embodiments, the weightsensor and controller can determine whether the IV has been filled witha desired amount of diluent. In some embodiments, the memory can includea database or lookup table indicating which transfer stations areassociated with which IV bags (which can be especially useful whenmultiple transfer stations are associated with a single IV bag). Theinformation can be input by the user via the user interface or byscanning bar codes on the IV bags and transfer stations. If thecontroller determines that the IV bag assembly is not properly attached(e.g., no IV bag attached, or incorrect IV bag weight for desireddiluent, or a wrong combination of transfer stations associated with theIV bag), the user interface can prompt the user to attach an IV bag orotherwise change the IV bag configuration. After the user makes thechanges, the process 2300 can return to block 2308 to confirm that theIV bag assembly is properly attached and configured.

If the IV bag assembly is properly attached, the process 2300 proceedsto block 2312 where the system transfers fluid(s) from the transferstation(s) to the IV bag, as will be described in greater detail below.

FIG. 24 is a flowchart that schematically shows an embodiment of amethod 2400 for transferring an amount of fluid from a vial to an IVbag. At block 2402, the controller determines an amount of fluid to betransferred. In some embodiments, the amount can be specified directlyby the fluid transfer command. In some embodiments, the amount of fluid(e.g., medication or diluent) can be affected by the desiredconcentration and the concentration of the fluid contained in the vial.

At block 2404, the controller determines whether the transfer amount isgreater than the effective maximum volume of the syringe associated withthe transfer station. In some embodiments, the memory can include adatabase or lookup table that stores the sizes of the syringesassociated with the different transfer stations. The information can beinput by the user via the user interface or by scanning bar codes on thesyringes and transfer stations. In some embodiments, the effectivemaximum volume of a syringe is the volume of the syringe when theplunger is substantially fully retracted. In some embodiments, theeffective maximum volume of the syringe is the volume of the syringewhen the plunger is retracted by the maximum amount that the actuator isable to retract.

If the amount to be transferred is greater than the effective maximumvolume of the syringe, the method 2400 proceeds to block 2406 where thecontroller causes the plunger of the syringe to be withdrawn so as todraw the effective maximum volume of fluid from the vial into thesyringe. As the fluid is transferred to the syringe in block 2406, thesystem can monitor for air bubbles, in block 2408, which can indicatethat the fluid in the vial has run out. If a bubble is detected at block2408, the method 2400 can interrupt block 2406 and prompt the user toreplace the empty vial at block 2410. Once the vial has been replaced,the method 2400 can return to block 2406 and finish filling the syringe.

Once the syringe has been filled the method can proceed to block 2412where the system determines whether an IV bag is attached to the targetconnector portion of the relevant transfer station. In some embodiments,a weight or IR sensor can be used to detect the presence of an IV bag ora connector attached to the target connector portion. Because an IV bagcan be disconnected by mistake during a fluid transfer, in someembodiments the system can be configured to check for a connected IV bageach time the plunger of the syringe is to be advanced to drive fluidout of the syringe. In some embodiments, the system checks for anattached IV bag only at the start of the fluid transfer, so blocks 2412and 2414 can be omitted. If the IV bag is not attached, the method 2400can proceed to block 2414 where the user interface can prompt the userto reattach the IV bag. In some embodiments, the UI can provide an alertmessage to the user indicating that an error has likely occurred (e.g.,an IV bag was removed prematurely). Once the changes have been made, themethod 2400 can return to block 2412 to confirm that the IV bag isproperly attached. In some embodiments, if the IV bag is not properlyattached, the method 2400 can abort the fluid transfer, rather thanproceeding to block 2414, and display an error message or alert to theuser.

Once the system determines that the IV bag is attached, the method 2400can advance to block 2416 where the controller can cause the actuator toadvance the plunger of the syringe to drive the fluid out of the syringeand into the IV bag. At block 2418, the method can subtract theeffective max volume of the syringe (i.e., the amount added to the IVbag at block 2416) from the amount of fluid to be transferred. Then themethod 2400 can return to block 2404.

If, at block 2404, the controller determines that the amount to betransferred is less than the effective maximum volume of the syringe,the method 2400 can advance to block 2420 where the controller causesthe actuator to withdraw the plunger of the syringe by a distance todraw the remaining transfer amount of fluid into the syringe. Thecontroller can be configured to determine the distance to draw back theplunger based on the amount fluid remaining to be transferred and by thesize of the syringe, which can be stored in a database or lookup tablein the memory.

At block 2422, the system can monitor for air bubbles similarly to block2408. If an air bubble is detected, the process 2400 can interrupt block2420 and proceed to block 2424 where the user interface can prompt theuser to replace the empty vial. Once the vial has been replace themethod 2400 can return to block 2420 and finish filling the syringe withthe desired amount of fluid.

Once the syringe contains the remaining fluid to be transferred, theprocess can advance to block 2426, where the system determines whetheran IV bad is attached similar to block 2412. If no IV bag is properlyattached, the method 2400 can advance to block 2428, where the userinterface can prompt the user to reattach the IV bag. Once the changeshave been made the method 2400 can return to block 2426 to confirm thatan IV bag is properly attached. Then the method 2400 can advance toblock 2430 where the controller can cause the actuator to advance theplunger of the syringe to drive the fluid from the syringe into the IVbag.

The method 2400 can end at block 2432. In some embodiments, the method2400 can repeat for one or more additional fluids (e.g., a diluent oradditional medication for a compounding procedure) transferred from oneor more additional transfer stations. In addition, the blocks and orderillustrated are exemplary methods. Modification is also possible. Forexample, the system can detect whether a bag is attached (e.g., blocks2412, 2426) prior to drawing fluid into the syringe (e.g., blocks 2406,2420).

FIG. 25 is a flowchart that schematically shows an embodiment of amethod 2500 for confirming the successful transfer of fluid by checkingthe weight of the final IV bag. At block 2502, the controller candetermine an expected IV bag weight for the final IV bag filled with thetransferred fluid. The expected weight can be determined by the startingweight of the empty IV bag (or the starting weight of the IV bag withdiluent), and the amount and density of fluid to be transferred into theIV bag.

At block 2504, the system can measure the actual IV bag weight. In someembodiments, the system can include a weight sensor and canautomatically measure the weight of the IV bag once the fluid transferis complete. In some embodiments, the user interface can prompt the userto weigh the IV bag and enter the weight. In some embodiments, the userinterface can prompt the user that the transfer is complete and displaythe expected weight for the IV bag. The user can then weigh the IV bagand compare the actual weight against the displayed expected weight.

At block 2506, the controller can compare the actual IV bag weight tothe expected IV bag weight. If the actual IV bag weight differs from theexpected IV bag weight by more than a threshold tolerance amount, themethod 2500 can determine that an error occurred during the fluidtransfer and advance to block 2510. At block 2510, the controller canattempt to determine possible causes of the fluid transfer failure. Manycircumstances can lead to a fluid transfer failure. For example, if theuser changes the type of fluid for a fluid transfer station withoutproperly updating the database, the IV bag can contain the correctamount of fluid but since the fluid can have a different density thefinal weight of the IV bag can be different from the expected amount. Ifthe user changes the syringe size for the transfer station withoutproperly updating the database the actuation of the plunger can transferan amount of fluid different than intended and the final weight of theIV bag can differ from the expected weight. The controller can beconfigured determine possible causes for the failure based at least inpart on the amount by which the actual IV bag weight differs from theexpected weight. At block 2512, the user interface can inform the userof the failure and can display one or more possible causes for thefailure to aid the user in trouble shooting the problem.

If the actual IV bag weight is within the threshold tolerance amount ofthe expected weight, the system can conclude that the fluid wastransferred successfully, and the method can advance to block 2508. Atblock 2508, the user interface can inform the user that the fluid wastransferred successfully. The threshold tolerance amount can bedetermined by several factors, including the precision of the weightsensors, the amount of fluid transferred, and the accuracy provided bythe syringe(s) used. It should be noted that some fluid transfer errorscan go undetected by checking the weight of the IV bag. For example, ifan incorrect fluid is used that has the same density as the correctfluid, the final IV bag will weigh the correct amount. However, bychecking the weight of the IV bag, many errors can be detected.

FIG. 26 is a partial sectional view that schematically shows anotherembodiment of a fluid transfer subsystem 2600 that can includes a vial2614, a syringe 2618, and a connector 2620. In some embodiments, thevial 2614, syringe 2618, and connector 2620 shown in FIG. 26 can be thesame as or similar to, for example, to the vial 314, syringe 318, andconnector 320 described above. In some embodiments, the connector 2620can include a main body portion 2642, a source connector portion 2636configured to connect to the vial 2614, a target connector portion 2638(partially shown in FIG. 26) configured to connect to an IV bag assembly(not shown in FIG. 26), and an intermediate connector portion 2640configured to connect to the syringe 2618.

In some embodiments, the source connector portion 2636 can similar tothe source connector portion 336 described above. The source connectorportion 2636 can be integrally formed with the main body portion 2642 ofthe connector 2620, or the source connector portion 2636 can beseparately formed and secured to the main body portion 2642, forexample, by a plastic welding adhesive or other manner as describedabove. In some embodiments, the source connector portion 2636 includes apiercing member 2670 which can include an elongate shaft 2672 andpointed tip 2674. The piercing member 2670 can be configured to puncturea septum 2660 formed in a cap 2659 of the vial 2614 when the vial 2614is pressed onto the connector 2620.

In some embodiments, the source connector portion can include a fluidextraction channel 2682 extending from an extraction aperture 2683formed in a portion of the piercing member 2670 to the main body portion2642 of the connector 2620. The fluid extraction channel 2682 can beconfigured to allow fluid 2666 to flow out of the vial 2614 and into theconnector 2620, e.g., when the plunger 2619 of the syringe 2618 iswithdrawn. In some embodiments, the connector 2620 can include a sourcecheck valve 2656 formed therein and configured to allow fluid to flowfrom the vial into the connector 2620 and prevent fluid from flowingfrom the connector 2620 into the vial 2614. In some embodiments, thesource check valve 2656 can be similar to the check valve 356 describedabove or it can be a duckbill valve formed in the fluid extractionchannel 2682, as schematically shown in FIG. 26. Many other variationsare possible.

The source connector portion 2636 can also include a regulator channel2690 extending from a regulator aperture 2692 up through a portion ofthe elongate shaft 2672 to an opening 2693 formed in the piercing member2670. The regulator channel 2690 can allow air to enter the connector2620 and flow into the vial 2614 as the fluid 2666 is withdrawn, therebymaintaining a substantially constant pressure inside the vial 2614. Insome embodiments, a regulator check valve 2655 can be formed in theregulator channel 2690 to prevent fluid 2666 from escaping from the vial2614 via the regulator channel 2690. The connector 2620 can also includea filter 2661 formed over the regulator aperture 2692 to preventcontaminants or other foreign particles from entering the regulatorchannel 2690 and contacting the fluid 2666. In some embodiments, thefilter 2661 can be permeable to air so that air is permitted to enterthe vial 2614 via the regulator channel 2690. In some embodiments, thefilter 2661 can be impermeable to the fluid 2666 and can be used inconjunction with, or in place of, the regulator check valve 2655 toprevent fluid 2666 from exiting the vial 2614 via the regulator channel2690.

In some embodiments, the source connector portion 2636 can differ fromthe source connector portion 336 by not including a bag to hold the airthat enters the vial 2614. Thus, the air that enters the vial 2614 candirectly contact the fluid 2666 contained therein. In some embodiments,the connector portion 2636 is only used for vials 2614 containing fluid2666 that will not react with, or otherwise be adversely affected by,the air. In some embodiments, the filter 2661 and/or regulator checkvalve 2655 can be configured to allow only certain gases, which will notadversely affect the fluid 2666, to enter the vial 2614.

The target connector portion 2638 can be similar to the target connectorportion 338 described above, the disclosure of which applies to theembodiment shown in FIG. 26. Only the mail connector portion 2652 of thetarget connector portion 2638 is shown in FIG. 26. The target connectorportion can be configured to provide fluid communication between theconnector 2620 and an IV bag assembly (not shown in FIG. 26) similar orthe same as the IV bag assembly 330 described above. The connector 2620can include a target check valve 2658 configured to allow fluid to flowfrom the connector into the IV bag assembly, e.g., when the plunger 2619of the syringe 2618 is advanced, and prevent fluid from flowing from theVI bag assembly into the connector 2620. The target check valve 2658 canbe similar or the same as the target check valve 358 described above, orit can be a duckbill valve as shown schematically in FIG. 26.

The intermediate connector portion 2640 can be configured to removablyreceive the syringe 2618 and provide a sealed fluid pathway between theconnector 2620 and the syringe 2618. In some embodiments, theintermediate connector portion 2640 can be the same as or similar to theintermediate connector portion 340 described above.

The fluid transfer subsystem 2600 can be used as a fluid transferstation on an automated fluid transfer system, which can be, forexample, similar to the automated fluid transfer system 600 describedabove.

FIG. 27A is a perspective view of an embodiment of a fluid transfermodule in the form of a connector 2700, which can be similar in manyregards to the connector 320 or any other connector disclosed herein.FIG. 27B is another perspective view of the connector 2700. Theconnector 2700 can be used to transfer fluid from a source container(e.g., a vial) to an intermediate measuring container (e.g., a syringe)and then to a target container (e.g., an IV bag). The connector 2700 caninclude a source connector portion 2702 configured to interface with thesource container (e.g., a vial), an intermediate connector portion 2704configured to interface with the intermediate measuring container (e.g.,a syringe), and a target connector portion 2706 configured to interfacewith the target container (e.g., an IV bag assembly).

The connector 2700 can function to transfer fluid from the sourcecontainer to the target container similarly to the connector 320 or theconnector 2600 or any other connector disclosed herein. Fluid can beextracted from a vial (not shown) through the fluid extraction aperture2708, and air can enter the vial via the air inlet 2710 and air outlet2712 to replace the volume of extracted fluid. The fluid extracted fromthe vial can be drawn through the connector 2700 and into the syringe(not shown) via the opening 2714 formed in the intermediate connectorportion 2704. A source check valve (hidden from view in FIGS. 27A-B) canbe configured to allow fluid to flow from the fluid extraction aperture2708 to the opening 2714 in the intermediate connector portion 2704while preventing fluid from flowing in the reverse direction back intothe vial. The fluid can be driven from the syringe into the connector2700 via the opening 2714, and the fluid can be directed into the targetconnector portion 2706 and into an IV bag assembly (not shown) attachedto the target connector portion 2706. A target check valve (hidden fromview in FIGS. 27A-B) can be configured to allow the fluid to flow fromthe opening 2714 in the intermediate connector portion 2704 to thetarget connector portion 2706 while preventing fluid from flowing in thereverse direction.

FIG. 28A is an exploded perspective view of the connector 2700. FIG. 28Bis another exploded perspective view of the connector 2700. Theconnector 2700 can include an upper housing member 2720 and a lowerhousing member 2722. The upper housing member 2720 can include thesource connector portion 2702 of the connector 2700, and the lowerhousing member 2722 can include the intermediate connector portion 2704of the connector 2700.

The upper housing member 2720 can include a piercing member 2724 made upof an elongate substantially cylindrical shaft 2726 and a pointed tip2728. The piercing member 2724 can be configured to pierce the septum ofa vial (not shown) when the vial is attached thereto. The upper housingmember 2720 can include retaining arms 2730 a-b configured to secure thevial to the connector 2700, as described herein. The piercing member2724 can include a fluid extraction aperture 2708 formed on one sidethereof. The fluid extraction aperture can be a slit that extends fromnear the end of the pointed tip 2728 down onto the shaft 2726, althoughopenings of other shapes can also be used. In some embodiments, the slitshape can facilitate the full extraction of fluid from the vial. A fluidpathway 2732 can extend from the fluid extraction aperture 2708 to afluid outlet opening 2734 formed in the bottom surface of the base 2736of the upper housing member 2720. The piercing member 2724 can alsoinclude an air outlet 2712 that allows air to enter the vial as fluid isextracted therefrom to equalize the pressure differential caused by theextraction of fluid. The air outlet 2712 can receive air from an airpathway 2738 that extends through the shaft 2726 and through the base2736 and to an air inlet opening 2740 formed in the base 2736 of theupper housing 2720.

The upper housing member 2720 can include a female end 2742 configuredto receive a male end 2744 of the target connector portion 2706. Thetarget connector portion 2706 can be similar to the other targetconnector portions described herein (e.g., 338), the disclosure of whichapplies also to the target connector portion 2706. The male end 2744 canbe secured to the female end 2742 by applying a plastic welding adhesive(such as Dichloromethane) to the outer surface of the male end 2744and/or to the inner surface of the female end 2742 before insertion. TheDichloromethane can chemically weld the outer surface of the male end2744 to the inner surface of the female end 2742. Other methods can beused to connect the male end 2744 to the female end 2742, such as sonicwelding, threading, adhesives, etc. It will also be understood that thetarget connector portion can include the female end of the interfacewhile the top housing member can include the male end thereof. Indeed,any suitable interface for securing the target connector portion 2706 tothe upper housing member 2702 can be used. In some embodiments, theconnection between the male end 2744 and the female end 2742 ishermetically sealed, and in some embodiments includes a sealing member(not shown), such as an O-ring, to provide the hermetic seal. A fluidpathway 2746 can extend from the opening in the female end 2742 to afluid inlet opening 2748 formed in the bottom surface of the base 2736of the upper housing member 2720.

The lower housing member 2722 can include a chamber 2750 enclosed by abase wall 2752 and by side walls 2754 having an open top. The chamber2750 can be configured to receive the base 2736 of the upper housingmember 2720 when the top housing member 2720 is secured to the bottomhousing member 2722. The side walls 2754 can include projections 2756a-b formed near the top thereof, which can be configured to mate withcorresponding slots 2758 a-b formed in the upper portion of the base2736 for provide a snap-fit connection between the top housing member2720 and the bottom housing member 2722. It will be understood that thetop housing member 2720 can be secured to the bottom housing member 2722using various other techniques including an adhesive, sonic welding, afriction-fit, or any other suitable manner. The side walls 2754 of thelower housing member 2722 can include a front cutout 2760 configured toreceive a portion of the female end 2742 therein. The side walls 2754can also include a back cutout 2762 which can be align with the airinlet opening 2740 so that air is allowed to flow enter the air pathway2738 by passing through the back cutout 2762 and through the air inletopening 2740.

A shaft 2764 can extend downward from the base wall 2752 of the lowerhousing member 2722, and the shaft 2764 can have a female end 2766configured to receive the male end of a syringe (not shown). The femaleend 2766 can include external threads 2768 configured to mate withinternal threads of the syringe for securing the syringe thereto. Afluid pathway 2770 can extend from the opening formed in the female end2766 up through the shaft 2764. The fluid pathway 2770 can include afork or branch that divides the fluid pathway 2770 so that a fluid inletopening 2772 and a fluid outlet opening 2774 are both in fluidcommunication with the fluid pathway 2770. The shaft 2764 can include anenlarged portion 2776 that is wider than the female end 2766 toaccommodate the fork or branch in the fluid pathway 2770.

When the top housing member 2720 is attached to the bottom housingmember 2722, the fluid outlet opening 2734 of the upper housing member2720 can align with the fluid inlet opening 2772 of the lower housingmember 2722 such that fluid can flow from the vial, through the fluidpathway 2732, out the fluid outlet opening 2734, in the fluid inletopening 2772, through the fluid pathway 2770, and into the syringe.Also, the fluid inlet opening 2748 of the upper housing member 2720 canalign with the fluid outlet opening 2774 of the lower housing member2722 such that fluid can flow from the syringe, through the fluidpathway 2770, out the fluid outlet opening 2774, in the fluid inletopening 2748, through the fluid pathway 2746, and to the targetconnector portion 2706.

A source check valve 2778 can be disposed between the top housing member2720 and the lower housing member 2722, and can be configured to allowfluid to flow from the fluid outlet opening 2734 to the fluid inletopening 2772 while preventing fluid from flowing in the reversedirection. The source check valve 2778 can be a duckbill check valve asshown in the illustrated embodiment, or any other form of check valvecapable of allowing fluid to flow in one direction while preventingfluid flow in the opposite direction.

A target check valve 2780 can also be disposed between the top housingmember 2720 and the lower housing member 2722, and can be configured toallow fluid to flow from the fluid outlet opening 2774 to the fluidinlet opening 2748 while preventing fluid from flowing in the reversedirection. The target check valve 2780 can be a duckbill check valve asshown in the illustrated embodiment, or any other form of check valvecapable of allowing fluid to flow in one direction while preventingfluid flow in the opposite direction.

An air check valve 2782 can be disposed between the base 2736 of theupper housing member 2720 and a side wall 2754 of the lower housingmember 2722. The check valve 2782 can be positioned between the backcutout 2762 and the air inlet opening 2740 such that air is permitted toflow from the back cutout 2762 to the air inlet opening 2740, but airand fluid are not allowed to flow out of the air inlet opening 2740. Theair check valve 2782 can be a duckbill check valve as shown in theillustrated embodiment, or any other form of check valve capable ofallowing fluid to flow in one direction while preventing fluid flow inthe opposite direction. In some embodiments, a filter (not shown) can beused in conjunction with or in place of the air check valve 2782. Thefilter can be placed between, or within one of, the back cutout 2762 andthe air inlet opening 2740. The filter can be permeable to air so thatair is permitted to enter the air passageway 2738. In some embodiments,the filter can be impermeable to the fluid to prevent fluid from exitingthe vial via the air pathway 2738. In some embodiments, a bag (notshown) at least partially disposed within the air passageway 2738 can beused to prevent the air that enters the vial from mixing with the fluid.For example, the piercing member 2724 can include a bag and can besimilar to the piercing member 370 discussed above in connection withFIGS. 5A-D.

FIG. 29A is a perspective view of a check valve 2900 which can be usedas the source check valve 2778, the target check valve 2780, and/or theair check valve 2782. In some embodiments, the source check valve 2778,the target check valve 2780, and the air check valve 2782 can each havethe same shape and size so that they are interchangeable, therebyreducing the cost (e.g., mold creation) that would be required toproduce two or three distinct check valve designs. The check valve 2900can include a base 2902, which can be cylindrical in shape, althoughother shapes can also be used. A pair of generally opposing bill members2904 a-b can extend upward from the base 2902. The bill members 2904 a-bcan abut against one another at their ends furthest from the base 2902forming a slit 2906 therebetween. In the check valve's 2900 relaxedstate, the slit 2906 can be closed as shown in FIGS. 29A-B. The base2902 can include an opening 2908 in fluid communication with a chamber2910 formed between portions of the bill members 2904 a-b.

FIG. 29C is a cross sectional view of the check valve 2900 in the closedconfiguration. When the slit 2906 is closed and fluid is directed to thecheck valve 2900 in the direction that the check valve 2900 isconfigured to block, as shown in FIG. 29C by fluid flow lines, theresulting pressure applied to the outside surfaces of the bill membersforces the slit closed. Thus, as greater pressure is applied, the slit2906 closes more strongly to prevent fluid flow in the undesireddirection. Likewise, when fluid is withdrawn from the fluid chamber2910, the bill members 2904 a-b are also drawn together causing the slit2906 to seal more tightly. FIG. 29D shows the check valve 2900 in theopen configuration as fluid is directed through the check valve 2900 inthe desired direction, as shown by fluid lines. When fluid is directedthrough the opening 2908 and into the chamber 2910, the resultingpressure applied to the inside surfaces of the bill members 2904 a-bcauses the bill members 2904 a-b to move away from one another forcingthe slit 2906 to open. Likewise, when fluid is drawn away from theoutside surfaces of the bill members 2904 a-b (with flow in the oppositedirection of the flow lines shown in FIG. 29C), the resulting pressurecan pull the bill members 2904 a-b apart to open the slit 2906. Thecheck valve 2900 can be formed from silicone or any other suitableresilient material.

Returning now to FIGS. 28A-B, the fluid inlet opening 2772 can be wideenough to receive the duckbill portion of the source check valve 2778,and the fluid inlet opening 2748 can be wide enough to receive theduckbill portion of the target check valve 2780. Thus, in someembodiments, the fluid inlet opening 2772 can be wider than the fluidoutlet opening 2774, and the fluid inlet opening 2748 can be wider thanthe fluid outlet opening 2734. The fluid outlet opening 2734 can includea widened end portion that produces a step 2735. The widened portion andthe step 2735 can be configured to receive the base of the source checkvalve 2778. The step 2735 can have a height that is less than the heightof the base of the source check valve 2778 so that the base of the checkvalve 2778 can be compressed between the top housing member 2720 and thelower housing member 2722 when they are attached. Thus, the compressedbase of the check valve 2778 can function to seal off the interfacebetween the fluid outlet opening 2734 and the fluid inlet opening 2772so that fluid can flow through the check valve 2778 without escaping.This can be particularly advantageous when a chemotherapy drug or otherhazardous fluid is transported through the connector 2700. The fluidinlet opening 2748 can also have a widened end portion that creates astep 2749 to receive and compress the base of the target check valve2780 to seal the interface between the fluid outlet opening 2774 and thefluid inlet opening 2748. The air inlet opening 2740 can also include awidened end portion that forms a step 2741 and receives the base of theair check valve 2782 to seal the interface between the back cutout 2762and the air inlet opening 2740. In some embodiments, all fluid flowpaths through the connector are sealed (e.g., hermetically sealed) suchthat no fluid (e.g., chemotherapy drugs or other hazardous materials)can escape during operation.

FIG. 30A shows the connector 2700, a vial 3000, and a syringe 3050 in anunattached configuration. FIG. 30B shows the connector 2700, the vial3000, and the syringe 3050 in an attached configuration. FIG. 30C showsa front view of the connector 2700. In FIGS. 30A-C, the connector 2700is illustrated without the target connector portion 2706. The vial 3000can include a body 3002, and a cap 3004, with a septum 3006 (hidden fromview in FIGS. 30A-B) disposed within the cap 3004. The vial can includea securing ring 3008 formed on the neck of the body 3002, and/or the cap3004 can overhang over the edge of the body 3002 forming a securing step3010. The vial 3000 can be similar to the vial 314 described herein orany other medical vial or any other suitable container of fluid. It willbe understood that various vial shapes and sizes can be used other thanthe vials shown herein. For example, the vial 3000 can be much largerthan the vials (e.g., 314 or 3000) shown. Also, in some embodiments,other fluid containers can be used in place the vials shown.

As mentioned above, the connector 2700 can include retaining arms 2730a-b for securing the vial 3000 to the connector 2700. The manner ofsecuring the vial 3000 to the connector 2700 will be discussed ingreater detail with reference to FIGS. 30A-C. The retainer arms 2730 a-bcan be general z-shaped, having a lower portion 2784 a-b, a middleportion 2786 a-b, and an upper portion 2788 a-b. The lower portions 2784a-b can extend outward from the base 2736 of the upper housing member2720. As can best be seen in FIG. 30C, the lower portions 2784 a-b canbe slightly curved and can angle upward slightly (e.g., at an angle ofat least about 10° and/or no more than about 20°, and in someembodiments at an angle of about 15°, from the horizontal plane). Themiddle portions 2786 a-b can extend inwardly from the ends of the lowerportions 2784 a-b and can angle upward at an angle of at least about 30°and/or no more than about 60°, and in some embodiments by an angle ofabout 45°, from the horizontal plane. The upper portions 2788 a-b canextend outwardly from the ends of the middle portions and can angleupward at an angle of at least about 30° and/or no more than about 60°,and in some embodiments by an angle of about 45°, from the horizontalplane. In some embodiments, the ends of the upward portions 2788 a-b canbe curved as best seen in FIG. 30C. Securing projections 2790 a-b can belocated at the junctions between the middle portions 2786 a-b and theupper portions 2788 a-b.

The retaining arms 2730 a-b can be formed of a material and thicknesssuch that the retaining arms can resiliently bend outwardly, causing thedistance between the securing projections 2790 a-b to increase. Toattach the vial 3000 to the connector 2700, the vial 3000 can bepositioned as shown in FIG. 30A, and the vial 3000 can be pushed towardthe connector 2700 such that the piercing member 2724 punctures throughthe septum 3006 of the vial 3000. As the cap 3004 of the vial 3000contacts presses against the top/inner surfaces of the upper portions2788 a-b of the retainer arms 2730 a-b, the retainer arms 2730 a-b canbe flexed away from one another until the cap 3004 slips past thesecuring projections 2790 a-b, at which point the retaining arms 2730a-b snap back. When the retaining arms 2730 a-b snap back, the securingprojections 2790 a-b can engage the securing step 3010 on the side ofthe cap 3004 facing the body 3002 of the vial 3000. In some embodiments,the vial can be advanced until the securing projections 2790 a-b engageswith the securing step 3010 on the cap 3004 (as shown in FIG. 30B) orwith the securing ring 3008. In some embodiments, the retaining arms2730 a-b can include indentations 2792 a-b that can be configured toreceive a portion of the vial body 3002 prevent the vial 3000 fromshifting once secured to the connector 2700. If the securing step 3010on the cap 3004 engages the securing projections 2790 a-b, the securingring 3008 can engage the indentations 2792 a-b (as shown in FIG. 30B).If the securing ring 3008 engages the securing projections 2790 a-b, theportion of the vial 3000 where the neck widens to the body 3002 can bereceived by the indentations 2792 a-b.

As shown in FIG. 30B, the piercing member 2724 can extend into the body3002 of the vial 3000 such that the fluid extraction aperture 2708 isplace into contact with the fluid inside the vial 3000. In someembodiments, the slit shape of the fluid extraction aperture 2708 canallow the fluid to remain in contact with the fluid extraction aperture2708 as the fluid is emptied from the vial 3000. For example, in someembodiments, a portion of the fluid extraction aperture 2708 does notfully pass through the septum so that when the vial 3000 is nearlyempty, the little remaining fluid can still be withdrawn through thefluid extraction aperture 2708. In some embodiments, at least a portionof the septum of the vial can be thicker than the length of the fluidextraction aperture 2708 so that when the piercing member 2724 isinserted through the septum the fluid extraction aperture 2708 is not insimultaneous communication with both the interior and exterior of thevial.

In some embodiments, the connector can include a slit 2894 that extendsthrough a portion of the base 2736 along a midline between the retainerarms 2730 a-b. The slit 2794 can facilitate the flexing of the retainerarms 2730 a-b so that the slit can widen as the arms 2730 a-b areseparated from each other. In some embodiments, the piercing member 2724can connect to the base 2736 of the upper housing member 2720 within anindentation 2796 formed in the upper surface of the base 2736. Theindentation 2796 can also facilitate the flexing of the retainer arms2730 a-b because the arms 2730 can flex without directly applyingpressure to the piercing member 2708. In some embodiments, the slit 2794can extend out from the front and back sides of the indentation 2796.

With further reference to FIGS. 30A-C, the syringe 3050 can be similarto the syringe 318 discussed above, or any other syringe discussedherein. The syringe 3050 can include a body 3052, a male luer tip 3054,and a shroud 3056 surrounding the male luer tip 3054. Internal threads3058 can be formed on the inside surface of the shroud 3056 to mate withthe external threads 2768 formed on the outside surface of the femaleend 2766.

It will be understood that the connector 2700 can be used in connectionwith an automated fluid transfer system (e.g., system 600). Whenattached to a fluid transfer station, the connector 2700 can align withsensors for optically detecting the presence of air in the fluid pathwaybetween the vial 3000 and the syringe 3050 as discussed above inconnection with FIGS. 17-19D. With further reference now to FIGS. 30B-C,in some embodiments the connector 2700 can be aligned such that thelight (e.g., light 676 or 1924) passes through the fluid pathway 2770(hidden from view in FIG. 30C) formed in the shaft 2764 within theregion 2798 between the enlarged portion 2776 of the shaft 2764 and thelocation where the upper end of the syringe shroud 3056 ends when thesyringe is attached (e.g., as shown in FIG. 30B). In some embodiments,all or a portion of the lower housing member 2722 can be made from amaterial that is transparent to the light transmitted through the region2798. In some embodiments, the entire shaft 2764 or the entire portionof the shaft below the enlarged portion 2776 thereof can be transparent.In some embodiments, the shaft 2764 includes a transparent windowportion that covers all or a portion of the region 2798, with theremainder of the lower housing member 2722 being made from a materialthat is opaque to the light.

FIG. 31A shows a cross sectional view of the connector 2700, the vial3000, and the syringe 3050 as fluid is drawn through the connector 2700from the vial 3000 to the syringe 3050. As the plunger (not shown) ofthe syringe 3050 is withdrawn, fluid can be drawn into the body 3052 ofthe syringe 3050 from the fluid pathway 2770 formed in the shaft 2764.The fluid pathway 2770 can fork or branch so that both the source checkvalve 2778 and the target check valve 2780 are exposed to the pressuredifferential caused by the fluid being withdrawn from the fluid pathway2770. The slit of the target check valve 2780 closes more tightly asfluid is drawn away from it and towards the syringe 3050. The slit ofthe source check valve 2778 opens as the fluid is drawn toward thesyringe. When the source check valve 2778 opens, fluid can be drawn fromthe source container (e.g., vial 3000) toward the syringe 3050 tocompensate for the pressure differential. Fluid can enter the fluidpathway 2732 via the fluid extraction aperture 2708, and flow throughthe source check valve 2778, into the fluid pathway 2770, and down intothe syringe 3050. As fluid is extracted from the vial 3000, air can bedrawn into the vial to compensate for the loss of fluid volume. The aircan pass through the back cutout 2762, through the air check valve 2782,through the air pathway 2738, and through the air outlet 2712 into thebody 3002 of the vial 3000.

FIG. 31B shows a cross sectional view of the connector 2700, the vial3000, and the syringe 3050 as fluid is driven through the connector 2700from the syringe 3050 to the target connector portion 2706 which leadsto the IV bad assembly (not shown). As the plunger (not shown) of thesyringe 3050 is advanced, fluid can be driven from the body 3052 of thesyringe 3050 into the fluid pathway 2770 formed in the shaft 2764. Thefluid pathway 2770 can fork or branch so that both the source checkvalve 2778 and the target check valve 2780 are exposed to the pressuredifferential caused by the fluid being driven into the fluid pathway2770. The slit of the source check valve 2778 closes more tightly asfluid is pressed against the outside surfaces of its bill members. Theslit of the target check valve 2780 opens as the fluid pushed into itschamber and its bill members are pushed away from each other. When thetarget check valve 2780 opens, fluid can pass through the target checkvalve 2780, through the fluid pathway 2746, and into the male end 2744of the target connector portion 2706. Although not shown in FIG. 31B, itwill be understood that the fluid can be driven through the targetconnector portion 2706 and into an IV bag that is attached thereto.

It will be understood that many variations and modifications can be madeto the connector 2700. For example, although the illustrated embodimentis shown having an upper housing member 2720 and a lower housing member2722, it will be understood that the main housing can be made up of adifferent number of housing members. Some features that are shown asintegrated components can be separately formed, and vice versa. Forexample, in some embodiments, the retaining arms 2730 a-b can beseparately formed and attachable to the upper housing member 2720. Also,features and elements that are shown as part of the upper housing member2720 may, in some embodiments, be formed as part of the lower housingmember 2722 and vice versa. For example, female end 2742 that isconfigured to receive the target connector portion 2706 can be formed aspart of the lower housing member 2702. Many other variations are alsopossible.

FIG. 32A is a perspective view of an embodiment of a fluid transfermodule in the form of a connector 3200, which can be similar in manyregards to the connector 320 or any other connector disclosed herein.FIG. 32B is another perspective view of the connector 3200. Theconnector 3200 can be used to transfer fluid from a source container(e.g., a vial) to an intermediate measuring container (e.g., a syringe)and then to a target container (e.g., an IV bag). The connector 3200 caninclude a source connector portion 3202 configured to interface with thesource container (e.g., a vial), an intermediate connector portion 3204configured to interface with the intermediate measuring container (e.g.,a syringe), and a target connector portion 3206 configured to interfacewith the target container (e.g., an IV bag assembly).

The connector 3200 can function to transfer fluid from the sourcecontainer to the target container similarly to the connector 320 or theconnector 2700 or any other connector disclosed herein. Fluid can beextracted from a vial (not shown) through the fluid extraction aperture3208, and air can enter the vial via the air inlet 3210 and air outlet3212 to replace the volume of extracted fluid. The fluid extracted fromthe vial can be drawn through the connector 3200 and into the syringe(not shown) via the opening 3214 formed in the intermediate connectorportion 3204. A source check valve (hidden from view in FIGS. 32A-B) canbe configured to allow fluid to flow from the fluid extraction aperture3208 to the opening 3214 in the intermediate connector portion 3204while preventing fluid from flowing in the reverse direction back intothe vial. The fluid can be driven from the syringe into the connector3200 via the opening 3214, and the fluid can be directed into the targetconnector portion 3206 and into an IV bag assembly (not shown) attachedto the target connector portion 3206. A target check valve (hidden fromview in FIGS. 32A-B) can be configured to allow the fluid to flow fromthe opening 3214 in the intermediate connector portion 3204 to thetarget connector portion 3206 while preventing fluid from flowing in thereverse direction.

FIG. 33A is an exploded perspective view of the connector 3200. FIG. 33Bis another exploded perspective view of the connector 3200. Theconnector 3200 can include an upper housing member 3220 and a lowerhousing member 3222. The upper housing member 3220 can include thesource connector portion 3202 of the connector 3200, and the lowerhousing member 3222 can include the intermediate connector portion 3204of the connector 3200.

The upper housing member 3220 can include a piercing member 3224 made upof an elongate substantially cylindrical shaft 3226 and a pointed tip3228. The piercing member 3224 can be configured to pierce the septum ofa vial (not shown) when the vial is attached thereto. The piercingmember 3224 can include a fluid extraction aperture 3208 formed on oneside thereof. The fluid extraction aperture can be a slit that extendsfrom near the end of the pointed tip 3228 down onto the shaft 3226,although openings of other shapes can also be used. The piercing member3224 can also include an air outlet 3212 that allows air to enter thevial as fluid is extracted therefrom to equalize the pressuredifferential caused by the extraction of fluid. The air outlet 3212 canreceive air from an air pathway 3238 a that extends through the shaft3226 and through the base 3236 and to an air inlet opening 3240 formedin the base 3236 of the upper housing 3220.

The upper housing member 3220 can include a male end 3242 configured toreceive a female end 3244 of the target connector portion 3206. Thetarget connector portion 3206 can be similar to the other targetconnector portions described herein (e.g., 338), the disclosure of whichapplies also to the target connector portion 3206. In the illustratedembodiment, the target connector portion can include the female end 3244of the interface while the top housing member can include the male end3242 thereof. Indeed, any suitable interface for securing the targetconnector portion 3206 to the upper housing member 3202 can be used. Themale end 3242 can be secured to the female end 3244 by applying aplastic welding adhesive (such as Dichloromethane) to the outer surfaceof the male end 3242 and/or to the inner surface of the female end 3244before insertion. The Dichloromethane can chemically weld the outersurface of the male end 3242 to the inner surface of the female end3244. Other methods can be used to connect the male end 3242 to thefemale end 3244, such as sonic welding, threading, adhesives, etc. Insome embodiments, the connection between the male end 3242 and thefemale end 3244 is hermetically sealed, and in some embodiments includesa sealing member (not shown), such as an O-ring, to provide the hermeticseal. A fluid pathway 3246 can extend from the opening in the male end3242 to a fluid inlet opening 3248 formed in the bottom surface of thebase 3236 of the upper housing member 3220.

The lower housing member 3222 can include a base 3250 configured to matewith the base 3236 of the upper housing member 3220. The base 3236 ofthe upper housing member 3220 can include a lip 3254 on the bottomsurface thereof, forming an indentation. The periphery of the topsurface of the base 3250 of the lower housing member 3222 can beconfigured to contact the bottom surface of the lip 3254 when attached.The upper housing member 3220 can be secured to the lower housing member3222 using an adhesive, or plastic welding material, or sonic welding,or a snap-fit, or any other suitable technique.

The lower housing member 3222 can include an air inlet 3210 and an airoutlet opening 3262 with a fluid pathway 3238 b extending therebetween.A shaft 3264 can extend downward from the base 3250 of the lower housingmember 3222, and the shaft 3264 can have a female end 3266 configured toreceive the male end of a syringe (not shown). The female end 3266 caninclude external threads 3268 configured to mate with internal threadsof the syringe for securing the syringe thereto. A fluid pathway 3270can extend from the opening formed in the female end 3266 up through theshaft 3264. The fluid pathway 3270 can include a channel 3271 thatdiverts from the main flow path. Thus the fluid pathway 3270 can providea fluid inlet opening 3272 and a fluid outlet opening 3274.

When the top housing member 3220 is attached to the bottom housingmember 3222, the fluid outlet opening 3234 of the upper housing member3220 can align with the fluid inlet opening 3272 of the lower housingmember 3222 such that fluid can flow from the vial, through the fluidpathway 3232, out the fluid outlet opening 3234, in the fluid inletopening 3272, through the fluid pathway 3270, and into the syringe.Also, the fluid inlet opening 3248 of the upper housing member 3220 canalign with the fluid outlet opening 3274 of the lower housing member3222 such that fluid can flow from the syringe, through the fluidpathway 3270, out the fluid outlet opening 3274, in the fluid inletopening 3248, through the fluid pathway 3246, and to the targetconnector portion 3206. Also, the air outlet opening 3262 can align withthe air inlet opening 3240 so that air is allowed to enter through theair inlet 3210, flow through the air pathway 3238 b, out the air outletopening 3262, in the air inlet opening 3240, through the air pathway3238 a, through the air outlet 3212 and into the vial.

A check valve assembly 3277 can be disposed between the top housingmember 3220 and the lower housing member 3222. The check valve assembly3277 can include a base which can be shaped to fit into the indentationformed by the lip 3254. The check valve assembly 3277 can include asource check valve 3278 configured to allow fluid to flow from the fluidoutlet opening 3234 to the fluid inlet opening 3272 while preventingfluid from flowing in the reverse direction. The source check valve 3278can be a dome valve as shown in the illustrated embodiment, or any otherform of check valve capable of allowing fluid to flow in one directionwhile preventing fluid flow in the opposite direction.

The check valve assembly 3277 can include a target check valve 3280configured to allow fluid to flow from the fluid outlet opening 3274 tothe fluid inlet opening 3248 while preventing fluid from flowing in thereverse direction. The target check valve 3280 can be a domed checkvalve as shown in the illustrated embodiment, or any other form of checkvalve capable of allowing fluid to flow in one direction whilepreventing fluid flow in the opposite direction.

The check valve assembly 3277 can include an air check valve 3282configured such that air is permitted to flow from the air outlet 3262to the air inlet opening 3240, but air and fluid are not allowed to flowout of the air inlet opening 3240. The air check valve 3282 can be adomed check valve as shown in the illustrated embodiment, or any otherform of check valve capable of allowing fluid to flow in one directionwhile preventing fluid flow in the opposite direction. In someembodiments, a filter (not shown) can be used in conjunction with or inplace of the air check valve 3282. The filter can be placed in or nearthe air inlet, or within the air pathways 3238 a-b. The filter can bepermeable to air so that air is permitted to enter the air passageway3238 a-b. In some embodiments, the filter can be impermeable to thefluid to prevent fluid from exiting the vial via the air pathway 3238a-b. In some embodiments, a bag (not shown) at least partially disposedwithin the air passageway 3238 a can be used to prevent the air thatenters the vial from mixing with the fluid. For example, the piercingmember 3224 can include a bag and can be similar to the piercing member370 discussed above in connection with FIGS. 5A-D.

Although the domed check valves 3278, 3280, 3282 are shown as beinginterconnected by the base 3279, it will be understood that the domedcheck valves 3278, 3280, 3282 can be separately formed. A domed checkvalve can include a dome having a convex side and a concave side. One ormore slits 3281 can be formed in the dome. Although a single slit isshown in the illustrated embodiment, it will be understood that twocrossing slits, or various other slit configurations can be used. In thedomed check valve's relaxed state, the slit can be closed.

When the slit 3281 is closed and fluid is directed to the check valve3278, 3280, 3282 in the direction that the check valve 3278, 3280, 3282is configured to block, the resulting pressure that pushes on the convexside forces the slit 3281 closed. Thus, as greater pressure is applied,the slit 3281 closes more strongly to prevent fluid flow in theundesired direction. Likewise, when fluid is withdrawn from the concaveside, the slit 3281 is sealed more tightly. When fluid is pushed towardthe concave side, the resulting pressure causes the dome to flexoutwardly such that the slit 3281 opens. Likewise, when fluid is drawnaway from the convex side, the resulting pressure can pull the domemembers such that they flex outwardly and the slit 3281 opens. The checkvalve assembly 3277 can be formed from silicone or any other suitableresilient material.

With further reference to FIGS. 33A-B, the fluid inlet opening 3272 canbe wide enough to receive the dome portion of the source check valve3278, and the fluid inlet opening 3248 can be wide enough to receive thedome portion of the target check valve 3280. Thus, in some embodiments,the fluid inlet opening 3272 can be wider than the channel 3271 thatfunctions as the fluid outlet opening 3274, and the fluid inlet opening3248 can be wider than the fluid outlet opening 3234. The indentationformed by the lip 3254 can have a height that is less than the height ofthe base 3279 of the check valve assembly 3277 so that the base 3279 canbe compressed between the top housing member 3220 and the lower housingmember 3222 when they are attached. Thus, the compressed base 3279 ofthe check valve assembly 3277 can function to seal off the interfacesbetween the upper housing member 3220 and the lower housing member 3222so that fluid can flow therethrough without escaping. This can beparticularly advantageous when a chemotherapy drug or other hazardousfluid is transported through the connector 3200. In some embodiments,all fluid flow paths through the connector 3200 are sealed (e.g.,hermetically sealed) such that no fluid (e.g., chemotherapy drugs orother hazardous materials) can escape during operation.

FIG. 34A shows a cross sectional view of the connector 3200, the vial3000, and the syringe 3050 as fluid is drawn through the connector 3200from the vial 3000 to the syringe 3050. As the plunger (not shown) ofthe syringe 3050 is withdrawn, fluid can be drawn into the body 3052 ofthe syringe 3050 from the fluid pathway 3270 formed in the shaft 3264.The fluid can be drawn in from the pathway 3270 including the channel3271 so that both the source check valve 3278 and the target check valve3280 are exposed to the pressure differential caused by the fluid beingwithdrawn from the fluid pathway 3270. The slit of the target checkvalve 3280 closes more tightly as fluid is drawn away from it andtowards the syringe 3050. The slit of the source check valve 3278 opensas the fluid is drawn toward the syringe. When the source check valve3278 opens, fluid can be drawn from the source container (e.g., vial3000) toward the syringe 3050 to compensate for the pressuredifferential. Fluid can enter the fluid pathway 3232 via the fluidextraction aperture 3208, and flow through the source check valve 3278,into the fluid pathway 3270, and down into the syringe 3050. As fluid isextracted from the vial 3000, air can be drawn into the vial 3000 tocompensate for the loss of fluid volume. The air can pass through theair inlet 3210, through the air pathway 3238 b, through the air checkvalve 3282, through the air pathway 3238 a, and through the air outlet3212 into the body 3002 of the vial 3000.

FIG. 34B shows a cross sectional view of the connector 3200, the vial3000, and the syringe 3050 as fluid is driven through the connector 3200from the syringe 3050 to the target connector portion 3206 which leadsto the IV bad assembly (not shown). As the plunger (not shown) of thesyringe 3050 is advanced, fluid can be driven from the body 3052 of thesyringe 3050 into the fluid pathway 3270 formed in the shaft 3264. Thefluid can enter the channel 3271 so that both the source check valve3278 and the target check valve 3280 are exposed to the pressuredifferential caused by the fluid being driven into the fluid pathway3270. The slit of the source check valve 3278 closes more tightly asfluid is pressed against the convex surface of its dome. The slit of thetarget check valve 3280 opens as the fluid pushed against the concavesurface of its dome. When the target check valve 3280 opens, fluid canpass through the target check valve 3280, through the fluid pathway3246, and into the female end 3244 of the target connector portion 3206.Although not shown in FIG. 34B, it will be understood that the fluid canbe driven through the target connector portion 3206 and into an IV bagthat is attached thereto.

It will be understood that the connector 3200 can be used in connectionwith an automated fluid transfer system (e.g., system 600). Whenattached to a fluid transfer station, the connector 3200 can align withsensors for optically detecting the presence of air in the fluid pathwaybetween the vial 3000 and the syringe 3050 as discussed above inconnection with FIGS. 17-19D. With further reference now to FIGS. 34A-B,in some embodiments the connector 3200 can be aligned such that thelight (e.g., light 676 or 1924) passes through the fluid pathway 3270formed in the shaft 3264 within the region 3298 above the location wherethe upper end of the syringe shroud 3056 ends when the syringe 3050 isattached. In some embodiments, all or a portion of the lower housingmember 3222 can be made from a material that is transparent to the lighttransmitted through the region 3298. In some embodiments, the entireshaft 3264 can be transparent. In some embodiments, the shaft 3264includes a transparent window portion that covers all or a portion ofthe region 3298, with the remainder of the lower housing member 3222being made from a material that is opaque to the light.

It will be understood that many variations and modifications can be madeto the connector 3200. For example, although the illustrated embodimentis shown having an upper housing member 3220 and a lower housing member3222, it will be understood that the main housing can be made up of adifferent number of housing members. Also, features and elements thatare shown as part of the upper housing member 3220 may, in someembodiments, be formed as part of the lower housing member 3222 and viceversa.

FIG. 35A is a perspective view of an embodiment of a connector 3500,which can be similar in many regards to the connector 350 or any otherconnector disclosed herein. FIG. 35B is another perspective view of theconnector 3500. The connector 3500 can be used to transfer fluid from asource container (e.g., a vial) to an intermediate measuring container(e.g., a syringe) and then to a target container (e.g., an IV bag). Theconnector 3500 can include a source connector portion 3502 configured tointerface with the source container (e.g., a vial), an intermediateconnector portion 3504 configured to interface with the intermediatemeasuring container (e.g., a syringe), and a target connector portion3506 configured to interface with the target container (e.g., an IV bagassembly).

The connector 3500 can function to transfer fluid from the sourcecontainer to the target container similarly to the connector 350 or theconnector 2700 or any other connector disclosed herein. Fluid can beextracted from a vial (not shown) through the fluid extraction aperture3508, and air can enter the vial via the air inlet 3510 and air outlet3512 to replace the volume of extracted fluid. The fluid extracted fromthe vial can be drawn through the connector 3500 and into the syringe(not shown) via the opening 3514 formed in the intermediate connectorportion 3504. A source check valve (hidden from view in FIGS. 35A-B) canbe configured to allow fluid to flow from the fluid extraction aperture3508 to the opening 3514 in the intermediate connector portion 3504while preventing fluid from flowing in the reverse direction back intothe vial. The fluid can be driven from the syringe into the connector3500 via the opening 3514, and the fluid can be directed into the targetconnector portion 3506 and into an IV bag assembly (not shown) attachedto the target connector portion 3506. A target check valve (hidden fromview in FIGS. 35A-B) can be configured to allow the fluid to flow fromthe opening 3514 in the intermediate connector portion 3504 to thetarget connector portion 3506 while preventing fluid from flowing in thereverse direction.

FIG. 36A is an exploded perspective view of the connector 3500. FIG. 36Bis another exploded perspective view of the connector 3500. Theconnector 3500 can include an upper housing member 3520 and a lowerhousing member 3522. The upper housing member 3520 can include thesource connector portion 3502 of the connector 3500, and the lowerhousing member 3522 can include the intermediate connector portion 3504of the connector 3500.

The upper housing member 3520 can include a piercing member 3524 made upof an elongate substantially cylindrical shaft 3526 and a pointed tip3528. The piercing member 3524 can be configured to pierce the septum ofa vial (not shown) when the vial is attached thereto. The upper housingmember 3220 can include retaining arms 3230 a-b configured to secure thevial to the connector 2700 in a manner similar to that described inconnection with the retaining arms 2730 a-b. The piercing member 3524can include a fluid extraction aperture 3508 formed on one side thereof.The fluid extraction aperture can be a slit that extends from near theend of the pointed tip 3528 down onto the shaft 3526, although openingsof other shapes can also be used. The piercing member 3524 can alsoinclude an air outlet 3512 that allows air to enter the vial as fluid isextracted therefrom to equalize the pressure differential caused by theextraction of fluid. The air outlet 3512 can receive air from an airpathway 3538 a that extends through the shaft 3526 and through the base3536 and to an air inlet opening 3540 formed in the base 3536 of theupper housing 3520.

The upper housing member 3520 can include a female end 3542 configuredto receive a male end 3544 of the target connector portion 3506. Thetarget connector portion 3506 can be similar to the other targetconnector portions described herein (e.g., 338), the disclosure of whichapplies also to the target connector portion 3506. Any suitableinterface for securing the target connector portion 3506 to the upperhousing member 3502 can be used. The female end 3542 can be secured tothe male end 3544 by applying a plastic welding adhesive (such asDichloromethane) to the outer surface of the male end 3544 and/or to theinner surface of the female end 3542 before insertion. TheDichloromethane can chemically weld the outer surface of the male end3544 to the inner surface of the female end 3542. Other methods can beused to connect the male end 3544 to the female end 3542, such as sonicwelding, threading, adhesives, etc. In some embodiments, the connectionbetween the male end 3544 and the female end 3542 is hermeticallysealed, and in some embodiments includes a sealing member (not shown),such as an O-ring, to provide the hermetic seal. A fluid pathway 3546can extend from the opening in the female end 3542 to a fluid inletopening 3548 formed in the bottom surface of the base 3536 of the upperhousing member 3520.

The lower housing member 3522 can include a chamber 3550 enclosed by abase wall 3252 and by side walls 3254 and can have an open top. Thechamber 3250 can be configured to receive the base 3536 of the upperhousing member 2720 when the top housing member 3520 is secured to thebottom housing member 3522. The side walls 3554 can include a lip 3556near the top thereof which can be configured to mate with correspondingslots 3558 formed in the upper portion of the base 3536 for provide asnap-fit connection between the top housing member 3520 and the bottomhousing member 3522. It will be understood that the top housing member3520 can be secured to the bottom housing member 3522 using variousother techniques including an adhesive, sonic welding, a friction-fit,or any other suitable manner. The side walls 3554 of the lower housingmember 3522 can include a front cutout 3560 configured to receive aportion of the female end 3542 therein.

The lower housing member 3522 can include an air inlet 3510 and an airoutlet opening 3562 with a fluid pathway 3538 b extending therebetween.A shaft 3564 can extend downward from the base wall 3552 of the lowerhousing member 3522, and the shaft 3564 can have a female end 3566configured to receive the male end of a syringe (not shown). The femaleend 3566 can include external threads 3568 configured to mate withinternal threads of the syringe for securing the syringe thereto. Afluid pathway 3570 can extend from the opening formed in the female end3566 up through the shaft 3564. The fluid pathway 3570 can include afork or branch that divides the fluid pathway 3570 so that a fluid inletopening 3572 and a fluid outlet opening 3574 are both in fluidcommunication with the fluid pathway 3570.

When the top housing member 3520 is attached to the bottom housingmember 3522, the fluid outlet opening 3534 of the upper housing member3520 can align with the fluid inlet opening 3572 of the lower housingmember 3522 such that fluid can flow from the vial, through the fluidpathway 3532, out the fluid outlet opening 3534, in the fluid inletopening 3572, through the fluid pathway 3570, and into the syringe.Also, the fluid inlet opening 3548 of the upper housing member 3520 canalign with the fluid outlet opening 3574 of the lower housing member3522 such that fluid can flow from the syringe, through the fluidpathway 3570, out the fluid outlet opening 3574, in the fluid inletopening 3548, through the fluid pathway 3546, and to the targetconnector portion 3506. Also, the air outlet opening 3562 can align withthe air inlet opening 3540 so that air is allowed to enter through theair inlet 3510, flow through the air pathway 3538 b, out the air outletopening 3562, in the air inlet opening 3540, through the air pathway3538 a, through the air outlet 3512 and into the vial.

A check valve assembly 3577 can be disposed between the top housingmember 3520 and the lower housing member 3522. The check valve assembly3577 can include a source check valve 3578 configured to allow fluid toflow from the fluid outlet opening 3534 to the fluid inlet opening 3572while preventing fluid from flowing in the reverse direction. The sourcecheck valve 3578 can be a flap check valve as shown in the illustratedembodiment, or any other form of check valve capable of allowing fluidto flow in one direction while preventing fluid flow in the oppositedirection.

The check valve assembly 3577 can include a target check valve 3580configured to allow fluid to flow from the fluid outlet opening 3574 tothe fluid inlet opening 3548 while preventing fluid from flowing in thereverse direction. The target check valve 3580 can be a flap check valveas shown in the illustrated embodiment, or any other form of check valvecapable of allowing fluid to flow in one direction while preventingfluid flow in the opposite direction.

The check valve assembly 3577 can include an air check valve 3582configured such that air is permitted to flow from the air outlet 3562to the air inlet opening 3540, but air and fluid are not allowed to flowout of the air inlet opening 3540. The air check valve 3582 can be aflap check valve as shown in the illustrated embodiment, or any otherform of check valve capable of allowing fluid to flow in one directionwhile preventing fluid flow in the opposite direction. In someembodiments, a filter (not shown) can be used in conjunction with or inplace of the air check valve 3582. The filter can be placed in or nearthe air inlet 3510, or within the air pathway 3538 a-b. The filter canbe permeable to air so that air is permitted to enter the air pathway3538 a-b. In some embodiments, the filter can be impermeable to thefluid to prevent fluid from exiting the vial via the air pathway 3538a-b. In some embodiments, a bag (not shown) at least partially disposedwithin the air pathway 3538 a can be used to prevent the air that entersthe vial from mixing with the fluid. For example, the piercing member3524 can include a bag and can be similar to the piercing member 370discussed above in connection with FIGS. 5A-D.

FIG. 37 is a perspective view of a check valve assembly 3700 which canbe used as the check valve assembly 3577 discussed herein. The checkvalve assembly 3577 can include a base 3702 with a right opening 3704, acentral opening 3706, and a left opening 3708 formed therethrough. Aseries of raised ridges 3722 a can outline the openings 3704, 3706, 3708on the top side of the base 3702, and a series of raised ridges 3722 bcan outline the openings 3704, 3706, 3708 on the bottom side of the base3702. A right divider 3710 can divide the right opening 3704 from thecentral opening 3706. A left divider 3712 can divide the left opening3708 from the central opening 3706.

A right flap 3714 can extend from the right divider 3710 into the rightopening 3704. The right flap 3714 can be sized so as to cover asubstantial portion of the right opening 3704 but leaving a narrow openarea surrounding the right flap 3714. A left flap 3716 can extend fromthe left divider 3712 into the left opening 3708. The left flap 3716 canbe sized so as to cover a substantial portion of the left opening 3708but leaving a narrow open area surrounding the left flap 3716. A firstcentral flap 3718 can extend from the right divider 3710 into thecentral opening 3706. A second central flap 3720 can extend from theleft divider 3712 into the central opening 3706. The first and secondcentral flaps 3718, 3720 can be configured to fill a substantial portionof the central opening 3706 but leaving a narrow open area surroundingthe first and second central flaps 3718, 3720.

The flaps 3714, 3716, 3718, 3720 can resiliently deform to open a fluidpathway. The flaps 3714, 3716, 3718, 3720 are shown in FIG. 37 inrelaxed positions. However, if a force (e.g., fluid pressure) is appliedto one side of a flap 3714, 3716, 3718, 3720, the flap 3714, 3716, 3718,3720 can be displaced in the direction of the applied force. In someembodiments, the flaps 3714, 3716, 3718, 3720 can pivot or hinge on thedividers 3710, 3712 and/or the flaps 3714, 3716, 3718, 3720 themselvescan bend to assume a curved shape. The manner in which the flaps 3714,3716, 3718, 3720 operate as check valves will be described in greaterdetail below.

In some embodiments, the check valve assembly 3700 can be symmetricalacross the x-y plane, the x-z plane, and/or the y-z plane. This symmetrycan facilitate assembly of the connector because the check valveassembly 3700 cannot be inserted backwards or upside-down.

Returning now to FIGS. 36A-B, the check valve assembly 3577 can includea source check valve 3578 (e.g., second central flap 3720), and a targetcheck valve 3580 (e.g., right flap 3714), and an air check valve 3582(e.g., left flap 3716). In some embodiments, the check valve assembly3577 can include an extra flap 3583 (e.g., first central flap 3718) thatdoes not function as a check valve. The extra flap 3581 can be includedto maintain the symmetry of the check valve assembly 3577 to simplifyassembly of the connector 2500.

With further reference to FIGS. 33A-B, the fluid inlet opening 3572 canbe wide enough to allow the source check valve 3578 to swing open, butthe fluid outlet opening 3534 can fit flush against the flap of thesource check valve 3578, thereby allowing the flap of the source checkvalve 3578 to open only in the direction toward the fluid pathway 2770.The fluid inlet opening 3548 can be wide enough to allow the targetcheck 3580 valve to swing open, but the fluid outlet opening 3574 canfit flush against the flap of the target check valve 3580, therebyallowing the flap of the target check valve 3580 to open only in thedirection toward the fluid pathway 3546. The air inlet opening 3540 canbe wide enough to allow the air check valve 3582 to swing open, but theair outlet opening 3562 can fit flush against the flap of the air checkvalve 3582, thereby allowing the flap of the air check valve 3582 toopen only in the direction toward the fluid pathway 3538 a. Thefunctionality of the check valves 3578, 3580, and 3582 can also be seenin FIGS. 38A-B which will be discussed below.

The height of the base 3702 and/or ridges 3722 a-b of the check valveassembly 2577 can be configured such that the base 3702 and/or ridges3722 a-b are compressed between the top housing member 3520 and thelower housing member 3522 when they are attached. Thus, the compressedbase 3702 and/or ridges 3722 a-b of the check valve assembly 2577 canfunction to seal off the interfaces between the upper housing member3520 and the lower housing member 3522 so that fluid can flowtherethrough without escaping. This can be particularly advantageouswhen a chemotherapy drug or other hazardous fluid is transported throughthe connector 3500. In some embodiments, all fluid flow paths throughthe connector 3500 are sealed (e.g., hermetically sealed) such that nofluid (e.g., chemotherapy drugs or other hazardous materials) can escapeduring operation.

FIG. 38A shows a cross sectional view of the connector 3500, the vial3000, and the syringe 3050 as fluid is drawn through the connector 3500from the vial 3000 to the syringe 3050. As the plunger (not shown) ofthe syringe 3050 is withdrawn, fluid can be drawn into the body 3052 ofthe syringe 3050 from the fluid pathway 3570 formed in the shaft 3564.Because the fluid pathway 3570 forks or branches, both the source checkvalve 3578 and the target check valve 3580 are exposed to the pressuredifferential caused by the fluid being withdrawn from the fluid pathway3570. The pressure differential caused by the fluid being withdrawn fromthe fluid pathway 3570 pulls the flap of the target check valve 3580more firmly closed against the base wall 3552 because the fluid outletopening 3574 is not wide enough to accommodate the flap. The pressuredifferential can pull the flap of the source check valve 3578 open. Whenthe source check valve 3578 opens, fluid can be drawn from the sourcecontainer (e.g., vial 3000) toward the syringe 3050 to compensate forthe pressure differential. Fluid can enter the fluid pathway 3532 viathe fluid extraction aperture 3508, and flow past the source check valve3578, into the fluid pathway 3570, and down into the syringe 3050. Theextra flap 3583 can also be pulled down into the fluid inlet opening3572 toward the fluid pathway 3570. In some embodiments, the extra flap3583 does not function as a check valve and does not substantiallyaffect the flow of fluid in either the relaxed or deformedconfiguration. In some embodiments, the extra flap 3583 can be omitted.As fluid is extracted from the vial 3000, air can be drawn into the vial3000 to compensate for the loss of fluid volume. The air can passthrough the air inlet 3510, through the air pathway 3538 b, past the aircheck valve 3582, through the air pathway 3538 a, and through the airoutlet 3512 into the body 3002 of the vial 3000.

FIG. 38B shows a cross sectional view of the connector 3500, the vial3000, and the syringe 3050 as fluid is driven through the connector 3500from the syringe 3050 to the target connector portion 3506 which leadsto the IV bad assembly (not shown). As the plunger (not shown) of thesyringe 3050 is advanced, fluid can be driven from the body 3052 of thesyringe 3050 into the fluid pathway 3570 formed in the shaft 3564. Thefluid pathway 3570 can fork or branch so that both the source checkvalve 3578 and the target check valve 3580 are exposed to the pressuredifferential caused by the fluid being driven into the fluid pathway3570. The pressure differential caused by the fluid being driven intothe fluid pathway 3570 can push the flap of the source check valve 3578more firmly closed against the bottom surface of the base 2536 becausethe fluid outlet opening 3534 is not wide enough to accommodate theflap. The flap of the target check valve 3580 can swing open as thefluid pushed against the flap. When the target check valve 3580 opens,fluid can flow past the target check valve 3580, through the fluidpathway 3546, and into the male end 3544 of the target connector portion3506. Although not shown in FIG. 38B, it will be understood that thefluid can be driven through the target connector portion 3506 and intoan IV bag that is attached thereto.

It will be understood that the connector 3500 can be used in connectionwith an automated fluid transfer system (e.g., system 600). Whenattached to a fluid transfer station, the connector 3500 can align withsensors for optically detecting the presence of air in the fluid pathwaybetween the vial 3000 and the syringe 3050 as discussed above inconnection with FIGS. 17-19D. With further reference now to FIGS. 38A-B,in some embodiments the connector 3500 can be aligned such that thelight (e.g., light 676 or 1924) passes through the fluid pathway 3570formed in the shaft 3564 within the region 3598 above the location wherethe upper end of the syringe shroud 3056 ends when the syringe 3050 isattached. In some embodiments, all or a portion of the lower housingmember 3522 can be made from a material that is transparent to the lighttransmitted through the region 3598. In some embodiments, the entireshaft 3564 can be transparent. In some embodiments, the shaft 3564includes a transparent window portion that covers all or a portion ofthe region 3598, with the remainder of the lower housing member 3522being made from a material that is opaque to the light.

It will be understood that many variations and modifications can be madeto the connector 3500. For example, although the illustrated embodimentis shown having an upper housing member 3520 and a lower housing member3522, it will be understood that the main housing can be made up of adifferent number of housing members. Also, features and elements thatare shown as part of the upper housing member 3520 may, in someembodiments, be formed as part of the lower housing member 3522 and viceversa.

Several connectors for transferring fluid are described herein (e.g.,connectors 320, 2600, 2700, 3200, 3500, 3910). It will be understoodthat many of the features described in connection with one connector canalso be applied to the other connectors disclosed herein. Manycomponents of the connectors can be interchangeable with correspondingcomponents of the other connectors. For example, the connectors 2700 and3500 are shown as having retaining arms for securing a vial thereto, andthe retaining arms can similarly be incorporated into the otherconnectors (e.g., 320 or 3200). Indeed, in some embodiments, theretaining arms can be removably attachable and can slide over thepiercing member and snap into place into a groove formed in the base ofthe shaft of the piercing member (see FIG. 32A). Each of the connectorscan be modified to incorporate the check valve types disclosed inconnection with each of the other connectors. In some embodiments, asingle connector can use different check valve types for different checkvalves. One possible configuration is to use a series of three duckbillcheck valves (e.g., as shown in connector 2700) but integrated into asingle check valve assembly and oriented similar to the check valveassembly of the connector 3200. Many other modifications are possible.

FIG. 39 is a perspective view of another example embodiment of a fluidtransfer system 3900. The fluid transfer station 3900 can be similar to,or the same as, fluid transfer systems 100 or 600 or any other fluidtransfer system discussed herein. Thus, the discussion associated withmany features of other fluid transfer systems described herein is alsoapplicable to the fluid transfer system 3900, even when not specificallyidentified.

The fluid transfer system can include a main housing 3902 that supportstwo transfer stations 3904 a-b, although any other suitable number oftransfer stations can be used (e.g. one, three, four, five, or moretransfer stations). The transfer stations 3904 a-b can be similar to, orthe same as, the transfer stations 604 a-f discussed above. Althoughonly transfer station 604 a is discussed in further detail below, itshould be understood that the transfer station 604 b can be the same astransfer station 604 a, or the transfer stations 604 a-b can vary (e.g.,having different sized syringes).

The transfer station 3904 a can be configured to receive a fluidicsassembly 3906 in a manner similar to that described in connection withtransfer station 604 a. The fluidics assembly 3906 can include a vial(not shown in FIG. 39), a vial adapter 3908, a fluid transfer module orconnector 3910, a syringe 3912, and an IV bag assembly 3914 (partiallyshown in FIG. 39). The transfer station can be configured to secure thesyringe 3912 and/or connector 3910 using, for example, a top connector3916, a middle connector 3918, and an end piece 3920. The transferstation 3904 a can include a motor (inside the housing 3902) to causethe end piece 3920 to move with respect to the middle connector 3918,thus withdrawing or advancing the plunger of the syringe 3912. In someembodiments, the motor can be a high precision stepping motor able towithdraw the plunger of the syringe 3912 by a precise distance, therebyfacilitating precision fluid transfer. In some embodiments, the system3900 can transfer amounts of fluid in increments within the range ofapproximately 0.05 milliliters to approximately 0.3 milliliters. In someembodiments, the system 3900 can transfer amounts of fluid in incrementsof about 0.1 milliliters. In some embodiments, the system 3900 cantransfer fluid at a rate in the range of about 10 to 70 milliliters perminute for each transfer station. In some embodiments, the rate can beabout 30 milliliters per minute for each fluid transfer station. In someembodiments, the system 3900 can transfer fluid with an error rate inthe range of about 0% to about 8% when transferring a volume of morethan 1 milliliter. In some embodiments, the error rate can be about 3%.

In some embodiments fluid transfer station 3904 a can include acompatibility mechanism configured to ensure that an approved connectoris used, to provide reliable accurate fluid transfer. The compatibilitymechanism can be a mounting feature (e.g., of the top connector 3916)that is configured specifically to fit with a portion of the connector3910. In some embodiments, the fluid transfer module or connector 3910can be a single-use, disposable portion. The fluid transfer module 3910can be provided with instructions to the user for inserting the fluidtransfer module 3910 into the electronically controlled fluid dispensingsystem to properly position and align the various components to allowfor fluid transfer and safety features. The fluid transfer module 3910also can be provided with instructions to the user for disconnecting thefluid transfer module 3910 after fluid transfer is completed. In someembodiments, the user instructions can include information indicatingthat the fluid transfer module should be disposed of in a biohazardreceptacle after a single use.

The fluid transfer station 3904 a can include a tray 3922 to support theIV bag assembly 3914. The tray 3922 can be similar to, or the same asthe tray 2272 described above. In some embodiments, the tray 3922 can besecured to the top connector 3916 or other portion of the housing 3902using screws or the tray 3922 can be inserted into a slot. Othersupports can be used. In some embodiments, the tray 3922 can pivot downwhen not in use, as will be discussed in greater detail below.

An electronically controlled fluid dispensing system, such as the fluidtransfer system 3900 can include a power switch 3926, and various inputand/or output ports 3928 for connecting external devices (e.g., akeypad, touchscreen, controller, printer, barcode scanner, monitor, orcomputer). In some embodiments a foot pedal can connect to one of theports 3928. The foot pedal can include a button or switch to start andstop the fluid transfer process. The housing 3902 can have support feet3930 extending therefrom, and handles 3932.

FIG. 40 is a perspective view of the fluidics assembly 3906 in anassembled configuration. FIG. 41 is a perspective exploded view of thefluidics assembly 3906 from a different angle than that shown in FIG.40. The fluid assembly 3906 can be used to transfer precise amounts offluid from the vial 3907 to the IV bag 3914. The fluidics assembly 3906includes a vial 3907, a vial adapter 3908 configured to provide fluidcommunication with the fluid (e.g., chemotherapy drug or othermedication) contained within the vial, a syringe 3912, an IV bagassembly 3914, and a connector 3910 for directing fluid from the vialadapter 3908 into the syringe 3912 and from the syringe toward the IVbag assembly. In some embodiments, the fluidics assembly 3906 can havefeatures similar to, or the same as, those of the other fluidics systemsdisclosed. In some embodiments, the fluidics assembly 3096 can beconfigured to allow the vial 3907 and vial adapter 3908 to be replaced(e.g., when the vial runs out of fluid) without replacing the connector3910 or syringe 3912. Unlike many of the connectors disclosed herein, inthe fluidics assembly 3906, air enters the vial 3907 via the vialadapter 3908 rather than through the connector 3910.

FIG. 42 is a perspective view showing the vial adapter 3908 and the vial3907 in a separated configuration, such as before the vial 3907 isattached to the vial adapter 3908. The vial adapter can have a topportion 3940 that is similar to, or the same as, the top of theconnector 2700, the connector 3500, or any of the other connectorsdescribed as being able to access fluid in a vial (or bag or other fluidsource container). For example, the top portion 3940 can include a spike3942 configured to piece the septum on the cap of the vial 3907 and arms3942 to retain the vial 3907 onto the vial adapter 3908.

Opposite the upper portion 3940, the vial adapter can include aconnector, which can be, for example, a female connector 3944. Theconnector 3944 can be, for example, a version of the Clave® connectormanufactured by ICU Medical, Inc., of San Clemente, Calif. Variousembodiments of a connector of this type are described in the '866patent. The female connector 3944 can seal the end of the vial adapter3908 such that no fluid is allowed to escape from the vial adapter 3908until a male connector is attached to the female connector 3944. Itshould be understood that in many embodiments discussed herein, the maleand female connectors can be switched. For example, the vial adapter3908 can include a male connector which is configured to mate with afemale connector on the connector 3910.

The vial adapter 3908 can include an air intake channel 3946 configuredto direct air into the vial 3907 to compensate for fluid removed fromthe vial 3907 to reduce the pressure differential. The air intakechannel 3946 can include a filter 3948 configured to allow air to passthrough the filter 3948 and toward the vial 3907 while also preventingfluid from passing through the filter. For example, the filter 3948 caninclude an air permeable but fluid impermeable membrane. The filter 3948can be a hydrophobic filter. In some embodiments, the vial adapter 3908can include a check valve in place of or in addition to the filter 3948.The vial adapter 3908 can also have a bag that is configured to increasein volume while preventing the input air to contact the fluid inside thevial 3907, similar to the bag 394 discussed above. Thus, the vial 3907can be vented by a mechanism independent of the connector 3910.

FIG. 43 is a cross sectional view of the vial 3907 and vial adapter 3908in an assembled configuration. As shown by the flow lines in FIG. 43.Air can pass through the filter 3948, through the air inlet channel3946, and into the vial 3907 to compensate for the fluid that is drawnout of the vial 3907 through a fluid channel 3950. The fluid channel3950 can pass through the spike 3942, and down through the femaleconnector 3944 as shown. Although the female connector 3944 is shown ina closed configuration in FIG. 43, it will be understood that the femaleconnector 3944 can be opened by the first male connector 3964 of theconnector 3910 to allow fluid to pass from the vial adapter 3908 to theconnector 3910.

FIG. 44 is a perspective view of the connector 3910. FIG. 45 is aperspective view of the connector taken from a different angle than theview of FIG. 44. FIG. 46 is a right-side view of the connector 3910.FIG. 47 is a back view of the connector 3910. FIG. 48 is a view of theconnector 3910. FIG. 49 is a top-down view of the connector 3910. FIG.50 is a bottom-up view of the connector 3910. FIG. 51 is a left-sideview of the connector 3910.

The connector 3910 can have features similar to, or the same as, thoseof the connector 2700 or any other connector disclosed here. Theconnector 3910 can include an upper housing portion 3960 and a lowerhousing portion 3962. A first male connector 3964 can be attached to afemale end 3966 of the upper housing portion. A second male connector3964 can be attached to a female end 3968 of the lower housing portions3962. The male connectors 3964, 3968 can be a version of the Spiros®closeable male connector manufactured by ICU Medical, Inc., of SanClemente, Calif. Various embodiments of connectors of this type aredescribed in the '920 Publication. A syringe interface 3972 can extenddown from the bottom of the lower housing portion 3962 to receive thesyringe 3912. A sensor region 3974 can also be positioned at the base ofthe lower housing portion 3962 and can be configured to allow light topass through the fluid pathway in the connector 3910 to detect thepresence of bubbles, which can indicate that the vial 3907 has run outof fluid. In some embodiments, the surface of the sensor region can beflat to allow light to pass through the wall of the sensor region 3974at an angle that is perpendicular to the surface, thereby allowing thelight to more reliably strike the corresponding sensor.

FIG. 52 is an exploded perspective view of the connector 3910. FIG. 53is an exploded perspective view of the connector 3910 taken from adifferent view than FIG. 52. The connector 3910 can be similar to theconnector 2700 in many respects. However, instead of including a vialadapter built into the upper housing portion, as is the case for theconnector 2700, the connector 3910 includes the first male connector3964 which is configured to removably interface with the femaleconnector 3944 of the separate vial adapter 3908. Thus, when the vial3907 runs out of fluid, the vial 3907 and vial adapter 3908 can bereplaced without replacing the connector 3910, syringe 3912, or anyother part of the fluidics assembly 3906. This can provide the benefitof reducing the amount of disposable pieces and fluid sent to wasteduring a vial replacement. Because the vial adapter is not part of theconnector 3910, the connector 3910 also differs from the connector 2700in that the connector 3910 does not include an air inlet channel or anair check valve. Other connectors which are described herein as havingan integrated vial adapter (e.g., the connectors 320, 3200, 3500) can besimilarly modified to be compatible with a separate vial adapter.

When the vial 3907, vial adapter 3908, connector 3910, syringe 3912, andIV bag assembly 3914 are connected, a source fluid pathway can be formedbetween the vial 3907 and the syringe 3912, and a target fluid pathwaycan be formed between the syringe 3912 and the IV bag. The connector3910 can include a source check valve 3976 positioned in the sourcefluid pathway to allow fluid to flow from the vial 3907 into the syringeand prevent fluid from flowing back into the vial 3907. The connector3910 can also include a target check valve 3978 positioned in the targetfluid pathway to allow fluid to flow from the syringe 3912 to the IV bagand prevent fluid from flowing from the IV bag back toward the syringe3912. The source and target check valves 3976, 3978 can be duck billcheck valves similar to the check valve 2900 discussed herein, althoughdome check valves or disc check valves or any other suitable check valvecan be used.

FIG. 54 is a cross sectional view of the connector 3910 and syringe 3912showing fluid flowing through the connector 3910 from the vial 3907 tothe syringe 3912. As the plunger of the syringe 3912 is withdrawn, fluidis drawn into the syringe. The pressure causes the source check valve3976 to open so that fluid is allowed to flow from the vial 3907 to thesyringe 3912. The pressure also causes the sides of the target checkvalve 3978 to bear against each other to maintain the target check valve3978 closed. Thus, fluid drawn into the syringe 3912 will be drawn fromthe vial 3907 and not the IV bag. As fluid is drawn out of the vial3907, air can enter the vial 3907 through the air inlet channel 3946 asdescribed above in connection with FIG. 43.

FIG. 55 is a cross sectional view of the connector 3910 and syringe 3912showing fluid flowing through the connector 3910 from the syringe 3912toward the IV bag assembly 3914. As the plunger of the syringe 3912 isadvanced, fluid is driven out of the syringe. The pressure causes thetarget check valve 3978 to open so that fluid is allowed to flow fromthe syringe 3912 toward the IV bag assembly 3914. The pressure alsocauses the sides of the source check valve 3976 to bear against eachother to maintain the source check valve 3976 closed. Thus, fluid drivenout the syringe 3912 will be directed to the IV bag and not back intothe vial 3907.

FIG. 56 is a perspective view of the IV bag assembly 3914. The IV bagassembly 3914 can include an IV bag 3980, a length of tubing 3982, and afemale connector 3984. The female connector 3984 can be removably orirremovably attached to the tubing 3982. The female connector 3984 canfunction to seal off the IV bag assembly 3914 so that no fluid canescape from the IV bag 3980 except when a male connector is attachedthereto.

FIG. 57 is an alternative IV bag assembly 5700 which may be used withthe fluidics assembly 3906 or with various other embodiments discussedherein. The IV bag assembly 5700 can include an IV bag 5702 and a lengthof tubing attached thereto 5704. A spike port 5706 can be positioned atthe end of the tubing 5704, and the spike port 5706 can include apiercing membrane or barrier that when closed prevents fluid fromentering or exiting the IV bag 5702. The female connector 5708 can havea spike 5710 attached thereto. The spike 5710 can be inserted into thespike port 5706 until it pierces the membrane or barrier therebyproviding access to the interior of the IV bag.

FIG. 58 is a perspective view of the top connector 3916 which includes abase member 4002 and a cassette 4004 in an engaged configuration. FIG.59 is an exploded perspective view of the top connector 3916 with thebase member and cassette 4004 in a disengaged configuration. FIG. 60 isa right-side view of the top connector 3916. FIG. 61 is a front view ofthe top connector 3916. FIG. 62 is a back view of the top connector3916. FIG. 63 is a left-side view of the top connector 3916. FIG. 64 isa top-down view of the top connector 3916. FIG. 65 is a bottom-up viewof the top connector 3916. FIG. 60 is a right-side view of the topconnector 3916. FIG. 60 is a right-side view of the top connector 3916.FIG. 61 is a front view of the top connector 3916. FIG. 62 is a backview of the top connector 3916. FIG. 63 is a left-side view of the topconnector 3916. FIG. 64 is a top-down view of the top connector 3916.FIG. 65 is a bottom-up view of the top connector 3916.

FIG. 66 is a front view of the cassette 4004. FIG. 67 is a back view ofthe cassette 4004. FIG. 68 is a right-side view of the cassette 4004.FIG. 69 is a top-down view of the cassette 4004. FIG. 70 is a bottom-upview of the cassette 4004. FIG. 71 is a left-side view of the cassette4004.

FIG. 72 is a front view of the base member 4002. FIG. 73 is a back viewof the base member 4002. FIG. 74 is a right-side view of the base member4002. FIG. 75 is a top-down view of the base member 4002. FIG. 76 is abottom-up view of the base member 4002. FIG. 77 is a left-view of thebase member 4002.

The top connector 3916 can have features that are similar to, or thesame as, the top connector 1900, or any other suitable top connectordiscussed herein. For example, the top connector can include a lightsource and sensor to detect an air bubble in the connector 3910, whichcan be an indication that the vial 3907 is empty. In some instances,infrared light can be used to detect the presence of air in theconnector 3910. For example, in some embodiments, light having awavelength of at least about 980 nanometers and/or no more than about1180 nanometers, or of at least about 1050 nanometers and/or no morethan about 1110 nanometers, or of approximately 1080 nanometers can beeffective for detecting air in the connector 3910. Other wavelengths oflight can also be used, such as light having a wavelength of at leastabout 850 nanometers and/or no more than about 1050 nanometers, or of atleast about 920 nanometers and/or no more than about 980 nanometers, orof approximately 950 nanometers. Light can be used that has a wavelengthof at least about 1380 nanometers and/or no more than about 1580nanometers, at least about 1450 nanometers and/or no more than about1510 nanometers, or about 1480 nanometers. One suitable optical sensorthat can be used is the DL20JJ 1480 nm sensor available from STM SensorTechnologie Munchen GmbH of Germany. Light can be directed between hole4006 a and hole 4006 b (hidden from view). The sensor region 3974 of theconnector 3910 can be positioned between hole 4006 a and hole 4006 bwhen it is properly attached to the top connector 3916.

In various embodiments disclosed herein which use a light source and alight sensor (e.g., to detect air or to detect the presence of an IVbag), the light source can pulse or flash at a predetermined frequency,and the light sensor can be configured to synchronize with the pulsinglight source. In some embodiments, the light sensor can be configured toignore light that is not pulsed at the predetermined frequency. Thus,the light sensor can differentiate between light emitted by thecorresponding light sensor (which is pulsed at the predeterminedfrequency) and light emitted from other sources (e.g., light from adifferent sensor that is pulsed at a different frequency, or ambientlight). In some embodiments, light sources can be used that provide aconstant beam of light.

The top connector 3916 can also include a light source and sensorconfigured to detect whether an IV bag assembly 3914 is attached to theconnector 3910. Light can be directed from hole 4008 a to hole 4008 b(hidden from view) and can intersect the second male connector 3968 at alocation that is not obstructed when the second male connector 3968 isclosed (when no IV bag is attached) and is obstructed when the secondmale connector 3968 is open (when an IV bag is attached). For examplethe location where the light intersects the second male connector 3968can be the location 4012 shown in FIG. 78. FIG. 78 is a cross sectionalview of the second male connector 3968 in the closed configuration, withno IV bag assembly attached thereto. The light can pass through theclear housing 4016 unobstructed when the second male connector 3968 isin the open configuration. When the light reaches the correspondingdetector, a signal can be generated that indicates that no IV bag isattached to the second male connector 3968. When the valve member 4018of the second male connector 3968 is pushed back to the openconfiguration (when the IV bag is attached), the opaque valve member4018 is positioned to occupy the location 4012 and obstruct the lightfrom reaching the corresponding detector. When no light reaches thedetector, a signal can be generated that indicates that the second maleconnector 3968 is in the open configuration and the IV bag assembly 3914is attached.

One suitable optical sensor that can be used with some embodiments fordetecting the presence of IV bag or other target container is the DL20RM645 nm sensor available from STM Sensor Technologie Munchen GmbH ofGermany. In some embodiments, an amplifier can be used to amplify thesignal of the light detector so that a relatively small amount of lightcan trigger the sensor. Thus, the amplifier can allow the sensor toaccurately identify a closed valve member 4018 in the second maleconnector 3968 even when a portion of the light is reflected orrefracted or otherwise redirected away from the light detector. Onesuitable amplifier that can be used is the V8-C or V8-D amplifieravailable from STM Sensor Technologie Munchen GmbH of Germany.

The top connector 3916 can also include a light source and detectorconfigured to detect the presence of the second male connector 3968regardless of whether it is open or closed. Light can be directedbetween hole 4010 a to hole 4010 b which is aligned with an opaqueportion of the second male connector 3968, e.g., at location 4014 asshown in FIG. 78. When light passes unobstructed between hole 4010 a andhole 4010 b (hidden from view) the detector can generate a signalindicating that the connector 3910 (of which the second male connector3968 is a part) is not present. When the light is obstructed by theplunger at location 4014 and does not reach the detector, a signal canbe generated that indicates that the second male connector 3968, and therest of the connector 3910 is present.

In some embodiments, the two optical sensors can both function to detectwhether an IV bag is attached. As further described below, if the lightfrom one of the optical sensors is unintentionally blocked from reachingthe corresponding light detector when the valve member is closed and noIV bag is present, the light from the other optical sensor can reach thecorresponding light detector to provide an indication that the valvemember is closed.

FIG. 79 is a perspective view showing the top connector 3916 cut toreveal the inner channels used to route wires for the light sources anddetectors described above. FIG. 80 is a perspective view showing the topconnector 3916 cut along a different axis to further reveal the channelsused to route wires. Wires can pass from the main housing 3902 to thetop connector 3916 via the hole 4020. The wires can then enter thechannel 4016 which leads to the holes 4006 a-b. As seen in FIG. 80, thechannels 4016 turn upward and lead to the holes 4008 a-b and the holes4010 a-b.

In some embodiments, the cassette 4004 can be shaped or otherwiseconfigured to be compatible with only authorized connectors 3910. Forexample, as can best be seen in FIG. 61 (front view of the top connector3916), the side walls 4003 of the cassette 4004 are slanted. The slantedside walls can correspond to the slanted side walls of the lower housingportion 3962 of the connector 3910. When an authorized connector 3910specifically designed for use with the fluid transfer system 3900 isattached to the top connector 3916, the tapered walls can fit snuggly toproperly position the connector 3910. If an unauthorized connector ofdifferent size or shape were to be connected to the top connector, itwould not fit properly with the top connector 3016. The tapered wallscan reliably position the connector 3910 with little or no freedom ofmovement in the vertical direction when the connector 3910 is attachedto the top connector 3916. The side walls can also restrict the freedomof movement of the connector along a horizontal direction thatintersects the side walls.

It can be beneficial to limit the connectors that can be used with thesystem 3900 to ensure accurate and reliable transfer of fluid. Forexample, as discussed below, in some embodiments, the proper priming ofthe connector 3910 relies in part on the internal volume of theconnector 3910. Thus, if a different connector 3910 having a differentinternal volume were used, the system 3900 may improperly prime theconnector 3910.

In some embodiments, the top connector 3916 can be configured to holdthe fluidics assembly 3906 in place using a securing mechanism. FIG. 81is a perspective view of the base member 4002 of the top connector 3916and the syringe 3912 cut and separated to reveal a channel 4022. FIG. 82is a top-down view taken at the cutting plane of FIG. 81. The channel4022 can be positioned such that when the syringe 3912 is fully attachedto the top connector 3916, the central axis of the syringe 3912 ispositioned slightly past the central axis through the channel 4022. Asshown in FIG. 82, one or more securing mechanisms 4024 can be positionedin the channel 4022. In their relaxed position, the securing mechanisms4024 can protrude partially past the channel 4022 and into the spaceshown occupied by the syringe 3912. The securing mechanisms 4024 can beresiliently movable along the axis down the channel 4022. As the syringe3912 is slid into the top connector 3916, the outer walls of the syringe3912 contact the securing mechanisms 4024 and displace them into thechannel 4022. Once the widest portion of the syringe 3912 clears thesecuring mechanisms 4024, the securing mechanisms 4024 return at leastpartially to their previous position, thereby securing the syringe 3912,and the rest of the fluidics assembly 3906 in place. The securingmechanisms 4024 can attach the fluidics assembly 3906 to the topconnector 3916 with little or no freedom of movement in the horizontaldirection that is substantially perpendicular to the channel 4022. Byrestricting the freedom of movement of the connector 3910, the connector3910 can reliably be aligned with respect to the optical sensors when itis attached to the top connector 3916.

In some embodiments, the tray 3922 can be positioned as shown in FIG. 39when in use and can be pivoted downward when not in use. The base member4002 can be configured to facilitate the pivoting of the tray 3922. FIG.83 is a right-side view of the base member 4002 with the tray 3922attached thereto. FIG. 84 is a right-side view of the base member 4002and the tray 3922 in a disengaged configuration. The tray 3922 can havea rear connector 4026 and a front connector 4028. The base member 4002can include a rear connection slot 4030 that turns rearward and a frontconnection slot 4032 that turn forward. It will be understood that theother side of the tray 3922 and base member 4002 can be symmetrical orsimilarly configured. To attach the tray 3922 to the base member 4002,the rear connector 4026 can be inserted into the read connection slot4030 until the rear connector 4026 reaches the rear depression 4034. Atthis point the tray 3922 can hand from the top connector base member4002 in the pivoted-down, unused position. The tray 3922 can be pivotedup until the forward connector 4028 enters the forward connection slot4032, and the tray can be shifted forward to the in-use position shownin FIG. 83 where the forward connector 4028 engages the forwarddepression 4036.

In some embodiments, the system 3900 (or other systems described herein)can prime the fluidics assembly 3906 before the desired volume of fluidis transferred from the vial 3907 to the IV bag 3980. When the userfirst assemblies the fluidics assembly, the internal volumes containair. FIG. 85 is flowchart that schematically shows an example embodimentof a method 8500 for priming a fluidics assembly.

At block 8504 a prime command is received. In some embodiments, the usercan initiate the prime by providing an instruction to the system 3900 toprime the fluidics assembly. In some embodiments, the system 3900 canask the user (via a user interface) whether the fluidics assembly shouldbe primed. In some embodiments, the system can recognize when a newfluidics assembly has been attached to the system. For example thesensor that detects the presence of the second male connector canindicate when a fluids assembly was added to the system. Also, in someembodiments, other sensors can be used. The sensor for detecting air inthe connector can also be configured to recognize whether the connectoritself is present in the light path. Other sensor types are alsopossible. For example the securing mechanisms discussed above caninclude a sensor for detecting whether they are displaced, indicate thatthe connector is present. In some embodiments, the sensor that is usedto detect air for determining whether vial has run empty can also beused to indicate whether the connector has already been primed bydetermining whether air is present in the connector. Thus, the systemcan be configured to determine when to automatically prime the fluidicsassembly and when to prompt the user to decide whether to prime.

At block 8506 the method determines whether the fluidics assembly isproperly attached. For example, the sensors discussed above can be usedto determine whether the fluidics assembly is present and whether aprime is needed. In some embodiments, this step is performed beforeblock 8504, as discussed above. If the fluidics assembly is not properlyattached, block 8508 can inform the user to attach or correct thefluidics assembly. If the fluidics assembly is properly attached, themethod 8500 advances to block 8510.

At block 8510, the syringe plunger is withdrawn by the distancenecessary to draw the priming volume into the syringe. The system canignore the signal from the air detector when priming the fluidicsassembly. Normally, the air detector can be used to prevent air frombeing drawn into the syringe. However, during the priming process, aircan be drawn into the syringe before the fluid reaches the syringe.

In some embodiments, the priming volume is the volume of the fluidicsassembly between (and excluding) the vial and the IV bag assembly whenthe syringe plunger is fully advanced. The priming volume can be thevolume of air in the fluidics assembly that needs to be pushed into theIV bag in order to bring the leading edge of fluid up to the entrance tothe IV bag, which may be the end of a connector attached to the bag viaa length of tubing. Thus, using the system 3900 as an example, thepriming volume can, for example, be equal to the internal volume of thevial adapter 3908, plus the internal volume of the connector 3910 (whichincludes the internal volume of the both male connectors 3964, 3968, theinternal volume in the internal chamber with the check valves, and theinternal volume of the syringe interface that is not occupied by thesyringe). In some embodiments, the internal volume of the IV bagassembly is excluded from the priming volume. However, in someembodiments the internal volume of the female connector 3984 and thetubing 3982 and any other portions of the IV bag assembly other than theIV bag itself are included. This can be useful if the parts of the IVbag assembly need to be replaced or removed prior to patient delivery.In some embodiments, the priming volume can include a portion of thesyringe's internal volume, such as the internal volume of the syringetip above the plunger's end. In some embodiments, the vial adapter canbe self priming, in which case, the internal volume of the vial adaptercan be excluded from the priming volume. For example, in someembodiments, the air in the fluid pathway of the vial can rise up intothe vial such that the fluid from the vial advances to the end of thefemale connector of the vial adapter.

In some embodiments, the system 3900 can calculate the priming volumebased on information acquired from the user or from sensors orotherwise. For example, the priming volume may vary depending on themodel of vial adapter that is used or the model of syringe being used.The system 3900 can prompt the user for information to be used forcalculating the priming volume. In some embodiments, the priming volumecan be a predetermined amount. For example, the priming volume can about0.7 milliliters.

At 8512 the system determines whether the IV bag is attached, forexample. If the IV bag is not attached properly, the system prompts theuser to properly attached the IV bag at 8514. If the IV bag is attached,the method 8500 advances to Block 8516. At 8516, the syringe drive thepriming volume into the connector, through the second male connector,and into the IV bag assembly. In some embodiments, the priming volumethat is drawn into and expelled from the syringe contains both air andfluid. If calculated and executed properly, in some embodiments, theleading edge of the fluid from the vial will be positioned at theentrance to the IV bag assembly, or in some cases at the entrance to theIV bag itself. At block 8518 the method can optionally prompt the userthat the fluidics assembly was successfully primed.

The method 8500 can be varied in many ways. For example, the checks atblocks 8506 and 8512 can be omitted or performed together or performedbefore block 8504. In some embodiments, the system does not perform aseparate priming procedure. Instead the system can merely add thepriming volume to the first volume of fluid that is transferred throughthe fluidics assembly.

FIG. 86 is a flowchart schematically showing a sample embodiment of amethod 8600 for transferring fluid from a vial to an IV bag. This methodcan be similar in some ways to the method 2400 discussed above. At block8602, the amount of fluid to be transferred is determined. At block8604, the system determines whether the amount remaining to betransferred is greater than the maximum volume that can be transferredby the syringe. If that remaining volume to be transferred is largerthan the maximum volume of the syringe, the method proceeds to block8606 where the system fills the syringe with the maximum syringe fluidvolume. As fluid is drawn into the syringe, the air detector monitorsfor the presence of air in the connector, as will be discussed ingreater detail in connection with FIG. 87.

At block 8608, the fluid is transferred from the syringe into the IVbag. In some embodiments the system can first perform a check to ensurethat the IV bag is properly attached before advancing the plunger of thesyringe. At block 8610, the maximum volume of the syringe is subtractedfrom the volume to be transferred, and the process returns to Block8604.

Once the amount of volume to be transferred is less than the maximumvolume of the syringe, the process advances to block 8612 where thesystem fills the syringe with the remaining amount of volume to betransferred. Again, while the fluid is drawn into the syringe, the airdetector monitors for the presence of air in the connector, as will bediscussed in greater detail in connection with FIG. 87. At block 8614the fluid is driven from the syringe into the IV bag. In someembodiments, the system can perform a check to ensure that the IV bag isproperly attached before pushing fluid into the IV bag. The process thenends at block 8616.

FIG. 87 is a flowchart that schematically illustrates an exampleembodiment of a method for replacing a vial of fluid to be transferred.At block 8702, the air detector identifies air in the connector, and atblock 8704 the system stops the transfer of fluid. In some embodiments,the system can prompt the user that air was detected and ask the user tocheck the vial. In some embodiments, the user interface can allow theuser to indicate that the vial is not yet empty, in which case, thedetected air was likely merely a small bubble. If the system receivesnotification that the vial is not empty at block 8706, the process willthen continue transferring the fluid at block 8708.

If the vial was indeed empty, the user can replace the vial and thecorresponding vial adapter. In some embodiments, the user can press abutton or otherwise indicate that the vial has been replaced. Oncenotification is received that the vial has been replaced at block 8712,the system then adds a replacement volume amount to the target fluidtransfer amount to compensate for the volume of air that was drawn fromthe vial before the air was detected. In some embodiments, the vialreplacement volume can be substantially equal to the internal volume ofthe flow path through the vial adapter, through the first maleconnector, and through the portion of the connector that is on thesyringe side of the target check valve and before the sensing locationwhere the air was detected. In some embodiments, the volume of the flowpath through the new vial adapter should also be added to the vialreplacement volume since the air in the new vial adapter will also bedrawn into the syringe and then pushed to the IV bag. As discussedabove, variations are possible. For example, for a self priming vialadapter, the volume for the replacement vial adapter does not need to beincluded. In some embodiments, the vial replacement volume can be 0.3milliliters.

At block 8716 the method continues with the fluid transfer process. Insome embodiments, the system can ignore air detected in the connectorfor a short time after the vial is replaced. In some embodiments, afterthe vial replacement volume has been added to the total transfer volume,the system can reevaluate whether an additional syringe draw will beneeded to reach the desired total fluid transfer amount.

FIG. 88 is a perspective view of another example embodiment of a fluidtransfer system 8800. The fluid transfer station 8800 can be similar to,or the same as, fluid transfer systems 3900, 100, or 600 or any otherfluid transfer system discussed herein. Thus, the discussion associatedwith many features of other fluid transfer systems described herein isalso applicable to the fluid transfer system 8800, even when notspecifically identified.

The fluid transfer system 8800 can include a main housing 8802 thatsupports four fluid transfer stations 8804 a-d, although any othersuitable number of fluid transfer stations can be used. In theillustrated embodiment, the fluid transfer stations 8804 a-b areconfigured to receive larger syringes than the fluid transfer stations8804 c-d. For example, fluid transfer stations 8804 a-b can beconfigured to use 20 milliliter syringes and fluid transfer stations8804 c-d can be configured to use 10 milliliter syringes, although othersizes of syringes can also be used. In some embodiments, a largersyringe (e.g., 20 milliliters) can allow fluid to be transferred fromthe source container to the target container at a faster rate, while asmaller syringe (e.g., 10 milliliters) can allow fluid to be transferredfrom the source container to the target container with greaterprecision. It will be understood that the fluid transfer stations 8804a-d can be configured to use various other syringe sizes, such assyringes of sizes between about 1 milliliter and about 100 millilitersor even syringes outside these ranges.

The fluid transfer station 8804 d is shown as having a fluidics assembly8806 attached thereto. The fluidics assembly can include a vial (notshown in FIG. 88), a vial adapter 8808, a connector 8810, a syringe8812, and an IV bag assembly 8814 (partially shown in FIG. 88), whichcan be similar to, or the same as, the corresponding componentsdiscussed in connection with the embodiment shown in FIG. 39, or anyother embodiments disclosed herein. The transfer station 8804 d can beconfigured to receive the syringe 8812 and/or the connector 8810 using,for example, a top connector 8816, a middle connector 8818, and a lowerconnector end piece 8820. A motor (hidden from view in FIG. 88) cancause the lower connector 8820 to move to withdraw and advance theplunger of the syringe 8812. As discussed above, the motor can be a highprecision stepping motor.

The fluid transfer station 8804 d can include a tray 8822 to support theIV bag (not shown in FIG. 88). The tray 8822 can be attached to the topconnector 8816 by a tray arm 8824 as will be discussed in greater detailbelow. The housing 8802 can include a step or foot 8830 positioned atthe base thereof to provide increased stability to the housing 8802, forexample to prevent the weight of the IV bags from tipping the housing8802 forward.

FIG. 89 is a perspective view of the top connector piece 8816. The topconnector piece can be similar to, or the same as the top connectorpieces 3916 or 1900 or any other top connector piece described herein.The top connector 8816 can include a base member 8902 and a removablecassette 8904. The base member 8902 can include a tray hole 8906 that isconfigured to receive the tray arm 8824 therein. The tray hole 8906 canbe positioned near a side edge of the base member 8902 and the tray arm8824 can similarly be attached near a side edge of the tray 8822 (asseen in FIG. 90). Thus, the tray 8822 can be positioned substantiallycentered in front of the top connector 8816 while the tray arm 8824 isoffset to the side so that the tray arm 8824 does not interfere with theattaching and detaching of the IV bag assembly.

With further reference to FIG. 90, the tray arm can have a substantiallycircular cross-sectional shape, or can otherwise be configured to allowthe tray arm 8824 to rotate within the tray hole 8906. The tray arm 8824can include a notch 8826 formed in the end opposite the tray 8822. Thetray arm 8824 can also include a groove 8828 that extends around all orpart of the circumference of the tray arm 8824.

FIG. 91 shows a rear perspective view of the top connector 8816 with thetray 8822 attached thereto in a first configuration wherein the tray8822 is positioned to support an IV bag. FIG. 92 shows another rearperspective view of the top connector 8816 with the tray 8822 attachedthereto in a second configuration wherein the tray 8822 is pivoted byabout 90° to provide unobstructed access to the cassette 8904. The usercan, for example, pivot the tray 8822 out of the way to the secondconfiguration (shown in FIG. 92) when attaching the syringe 8812 and/orthe connector 8810 to the fluid transfer station 8804 d. Then the usercan pivot the tray 8822 back to the first configuration (shown in FIG.91) and place the IV bag onto the tray 8822.

The top connector 8816 can include a stop plate 8908, which can bepositioned to occupy a portion of the tray hole 8906. The stop plate8908 can be secured to the back surface of the base member 8902 using,for example, a screw 8910, and the back surface of the base member 8902can have a recess shaped to receive the stop plate 8908 therein. Thestop plate 8908 can have a thickness that is configured to fit into thenotch 8826. When the tray 8822 is in the first configuration (shown inFIG. 91), the wall of the notch 8826 abuts against the side surface ofthe stop plate 8908 to prevent the tray 8822 from rotating past thefirst configuration. When the tray 8822 is rotated to the secondconfiguration (shown in FIG. 92), the wall of the notch 8826 abutsagainst the bottom surface of the stop plate 8908 to prevent the tray8822 from pivoting past the second configuration. In the illustratedembodiment, the stop plate 8908 is generally square shaped, such thatthe tray 8822 pivots by at least about 75° and/or no more than about105°, or in some cases about 90° between the first configuration and thesecond configuration. The shape of the stop plate 8908 and/or the shapeof the notch 8826 can be modified to change the rotational distancebetween the first and second tray configurations. For example, in someembodiments, the tray can pivot by about 180°, or by any angulardistance, between the first and second configurations. Also, the notchand/or the stop 8826 plate 8908 can be moved or modified so that thetray 8822 rotates in the opposite direction of that shown in FIGS.91-92.

FIG. 93 is a perspective view of the top connector 8816 and the tray arm8824 cut along a vertical plane that intersects the axis of the trayhole 8906. A top hole 8912 can be formed in the base member 8902 and canintersect the tray hole 8906. When the tray arm 8824 is inserted intothe tray hole 8906, the groove 8826 can align with the top hole 8912. Asecuring mechanism 8914 can be positioned in the top hole 8912 so thatthe securing mechanism 8914 can interface with the groove 8826 to securethe tray arm 8824 into the tray hole 8906. The securing mechanism 8914can have a tip 8916 that is attached to a spring such that the tip 8916can be axially displaced along the top hole 8912 in a direction awayfrom the tray hole 8906 to compress the spring. When the tray arm 8824is inserted into the tray hole 8906, the tray arm 8824 displaces the tip8916 of the securing mechanism 8914 and compresses the spring. Once thetray arm 8824 is inserted far enough for the groove 8826 to align withthe securing mechanism 8914, the tip 8916 can snap down into the groove8826. Thus, the securing mechanism 8914 can prevent the tray arm 8824from being accidentally removed from the tray hole 8806. To remove thetray arm 8824 from the tray hole 8906, the user can pull the tray arm8824 with enough force to compress the spring the drive the tip 8916 outof the groove 8826. The groove 8826 can be V-shaped to facilitate theremoval of the tray arm 8824.

Although not shown in the illustrated embodiment, the groove 8826 caninclude deepened portions that are configured to receive the tip 8916when the tray 8822 is in the first configuration and in the secondconfiguration, so that the tray 8822 can be “locked” into the firstconfiguration or into the second configuration. To break the “lock” andallow the tray 8822 to pivot, the user can apply a rotational force thatis sufficient to compress the spring and drive the tip 8916 out of thedeepened portion of the groove 8826. In some embodiments, the groove8826 can be omitted, and the tray arm 8824 can include two holesconfigured to receive the tip 8916 when in one of the first and secondconfigurations.

With further reference to FIG. 93, a cap 8918 can be placed over the topopening of the top hole 8912 to prevent debris from entering the hole8912. Two bushings 8920, 8922 can be positioned in the arm hole 8906,one near the stop plate 8908, and the other near the opening of the armhole 8906. Other numbers of bushings can be used, or the bushings can beomitted. The bushings 8920, 8922 can be made from a compressiblematerial and can have openings that are slightly smaller than thediameter of the tray arm 8824. Thus, the tray arm 8824 can compress thebushings 8920, 8922 as the tray arm 8824 is inserted into the tray hole8906. The pressure applied to the tray arm 8824 by the bushings 8920,8922 can provide additional stability to the tray 8824 to preventrattling or accidental rotation.

FIG. 94 is a cross sectional view of the top connector 8816 and tray arm8824 taken along a horizontal plane that intersects the axis of the trayhole 8906. A channel 8824 can extend through the base member 8902, andsecuring mechanisms 8926, 8928 can be positioned in the channel 8924 sothat the tips 8930, 8932 thereof extend out from the channel 8824. Inthe illustrated embodiment, the channel 8924 can intersect the tray hole8906. As similarly discussed in connection with FIG. 82, when a syringeis attached to the top connector 8816, the syringe can displace the tips8930, 8932 into the channel 8824 to compress the springs of the securingmechanisms 8826, 8828. Once the widest portion of the syringe passes thetips 8930, 8932, the springs can drive the tips 8930, 8932 toward eachother to secure the syringe to the top connector 8816. Securingmechanisms can similarly be used to secure other portions of thefluidics assembly 8806 (e.g., the connector 8810, or vial adapter 8808)to the transfer station 8804 d.

FIG. 95 is a perspective view of the cassette 8904, which can be similarto, or the same as, the cassette 4004, 1904, or any other suitablecassette described herein. The cassette 8904 can include holes 8940 a-bthat are configured to provide light path between a light source and alight sensor configured to detect air in the connector 8810. Thecassette 8904 can also provide holes 8942 a-b and holes 8944 a-b toprovide light paths between corresponding light sources and lightdetectors for detecting the presence of an IV bag assembly. The cassette8904 can include channels 8946 configured to provide a path for wires toreach the light sources and light detectors. The wires can pass througha hole in the base member 8902 (not shown in FIG. 95) and through a hole8948 that leads to the channels 8946. One channel can lead to the holes8942 b and 8944 b used in detecting the presence of the IV bag, andanother channel can branch off and lead to the hole 8940 b used fordetecting air. The other side of the cassette 8904 can have similarchannels leading to the holes 8904 a, 8942 a, and 8944 a. As discussedherein, the cassette 8904 can be removably attachable (e.g., using ascrew) to the base member 8902, so that the cassette 8904 can bedetached to provide access to the channels 8946 and to the light sourcesand light detector, if, for example, a component needs to be repaired orreplaced.

The cassette 8904 can have side walls 8950 that are tapered similar tothe cassette 4004 disclosed above. In the illustrated embodiment, thecassette 8904 has vertical side walls 8950 that are not tapered (as canbe seen in FIG. 96).

FIG. 97 is a cross sectional view of the connector 8810 with an outlineof the cassette 8904 shown in dotted lines. In the illustratedembodiment, the hole 8940 a for the air sensor aligns with the fluidpathway through the transition between the source connector piece 8952and the main connector body 8954. Thus, the light used to detect airpasses through a wall of the female end 8956, through a wall of the maleend 8958, through the fluid pathway 8960, then through an opposite wallof the male end 8958, and through an opposite wall of the female end8956. At least a portion of the female end 8956 and at least a portionof the male end 8958 can be substantially transparent to the light usedfor the air sensor. In some cases, at least the entire pieces that areintegrally formed with the female end 8956 and the male end 8958 can besubstantially transparent to the light of the air sensor.

The air detection light can intersect the fluid pathway at a location ofthe fluid pathway between the source check valve 8962 and the sourcecontainer (not visible in FIG. 97). In some cases, detecting air bubblesat a location upstream from the source check valve 8962 can reduce theoccurrence of false air bubble reads which can result from the turbulentflow of fluid through the source check valve 8962 even when the sourcecontainer has not run dry. In some embodiments, the light for the airsensor can pass through a fluid passageway that is less than about 4millimeters wide, or less than about 2 millimeters wide; and the fluidpassageway can be less than about quadruple the size, less than abouttriple the size, less than about double the size, or no larger than thehole 8940 a associated with the light for the air sensor. By causing thelight from the air sensor to cover a large portion of the fluid pathway,the sensor can more reliably identify the leading edge of air when thesource container has run dry.

FIG. 98 is a perspective view of a connector 9800 which can be similarto the connector 8810, or any other connector disclosed herein. A maleend 9806 of the source connector piece 9804 can connect to a female end9808 of the main body portion 9802 of the connector 9800. The female end9808 can have substantially flat outer surfaces 9810 where the lightfrom the air sensor intersects the female end 9808 to enter theconnector 9800, so that the light enters the connector at a directionthat is substantially normal to the surface 9810 (e.g., within about 10°or 5° or less of a direction normal to the surface 9810), therebyreducing the likelihood that the light will be refracted, or otherwisemisdirected, away from the light sensor.

In the embodiment illustrated in FIG. 98, the inner surface of thefemale end 9808 is curved and tapered so as to receive the curved andtapered outer surface of the male end 9806. However, in someembodiments, additional surfaces that intersect the light from the airsensor can be flat. For example, at least a portion of the outersurfaces and the inner surfaces of the male end 9806 and at least aportion of the inner surfaces of the female end can also be flat. Insome embodiments, each surface that the light for the air sensor passesthrough on the female end 9810 and the male end 9806 is a flat surface.In some embodiments, the male end 9806 and the female end 9808 can besubstantially index matched when they are mated together, therebyreducing refraction, or other misdirection, of the light away from thecorresponding sensor.

Returning now to FIG. 97, the target connector piece 8964 can align withthe holes 8942 a and 8944 a which are associated with two opticalsensors used for detecting an IV bag. In the illustrated embodiment, twooptical sensors can be used to determine whether an IV bag is attachedto the target connector piece 8964. As shown in FIG. 97 by the positionsof the holes 8942 a and 8944 a, a first light path can pass through thetarget connector piece 8964 at a location above the outside surface ofthe plunger 8966, and a second light path can pass through the side wallof the plunger 8966. As similarly explained in connection with FIG. 19D,when no IV bag is attached to the target connector 8964, the valvemember 8970 can be positioned in an open position, as shown in FIG. 97,to allow light to pass through the transparent components of the targetconnector piece 8964 to the corresponding light detectors. When thelight detectors detect the light, they can provide a signal indicatingthat the no target container is attached to the target connector piece8964. In response to that signal, a controller can stop or prevent thetransfer of fluid thereby preventing fluid (e.g., hazardous chemotherapydrugs) from being sprayed out of the target connector piece 8964 when noIV bag is attached thereto. In a manner similar to that discussed inconnection with FIG. 19E, when a connector of an IV bag assembly isattached to the target connector piece 8964, the valve member 8970 canbe displaced to an open position in which an opaque portion of the valvemember 8970 is positioned in between the holes 8942 a and 8942 b andalso between the holes 8944 a and 8944 b, to block light of the opticalsensors from reaching the light detectors. When the light detectors donot detect the light, they can provide a signal indicating that a targetcontainer is attached to the target connector piece 8964. In response tothe signal, a controller can begin, resume, or allow the transfer offluid through the connector.

In some embodiments, the connector 8810 can attach to the transferstation with some freedom of movement. Thus, in some instances, thelight paths may not align at the precise locations shown. In someinstances, one of the light paths may intersect the fluid pathway 8968through the plunger 8966. Accordingly, a frequency of light can be usedthat is not blocked by the fluid (e.g., chemotherapy drugs) beingtransferred through the connector 8810. In some embodiments, awavelength of light can be used that transmits well through water orsaline, which can be used as a solvent or diluent for the drugs. In someembodiments, visible light can be used (e.g., red colored light). Insome embodiments, light can be used for IV bag detection that has awavelength of at least about 545 nanometers and/or no more than about745 nanometers, or of at least about 615 nanometers and/or no more thanabout 675 nanometers, or of about 645 nanometers.

The embodiment of FIG. 97 includes two optical sensors for detecting anIV bag, and the controller can be configured to only allow fluid to betransferred through the target connector piece 8964 when both of thelight detectors do not detect light from their corresponding lightsources. While no IV bag is attached, if light from one of the opticalsensors is unintentionally blocked or diverted away from thecorresponding light detector, the light from the other optical sensorcan reach its corresponding light detector, thereby preventing a falseread in which the controller receives a signal that an IV bag isattached when no IV bag is present. Light from one of the opticalsensors can be unintentionally blocked or diverted by various differentcauses.

As mentioned above, in some cases, the connector 8810 can connect to thefluid transfer station with some freedom of movement. Thus, in someinstances, one of the light beams from one of the optical sensors maystrike the curved housing 8972 of the target connector piece 8964 at alocation other than at the locations shown in FIG. 97 associated withthe holes 8942 a and 8944 a. If the connector is shifted enough from theposition shown in FIG. 97, one of the light beams can strike the curvedhousing 8972 at a sufficiently oblique angle so that the light isreflected, refracted, or otherwise unintentionally diverted from itsnormal substantially linear path through the target connector piece8964. Thus, the light can fail to reach the corresponding light detectoreven when the valve member 8970 is in the closed position.

The light path formed between the holes 8942 a and 8942 b can be spacedfrom the light path formed between the holes 8944 a and 8944 b in adirection transverse to the longitudinal axis of the target connectorportion. The distance can be sufficient so that if one of the lightpaths intersects the curved housing 8972 at an angle that is obliqueenough to divert the light, the other light path will travel through thetarget connector piece 8964 at a location close enough to thelongitudinal axis so that the light strikes the curved housing 8972 atan angle that is close enough to normal so that the light is notdiverted away from the corresponding light detector. For example, theholes 8944 a and 8944 b can be positioned substantially directly belowthe holes 8942 a and 8942 b. The hole 8944 a can be spaced away from thehole 8942 a by a distance of at least about 2 millimeters and/or no morethan about 6 millimeters, or by about 4 millimeters. The hole 8944 b canbe spaced away from the hole 8942 b by substantially the same distance.

As similarly discussed above, in some embodiments, the connector 8810can be secured to the top connector 8816 such that it has little or nofreedom of movement so that the connector 8810 can reliably be alignedwith the optical sensors.

FIGS. 99-104 are cross sectional views of the target connector piece8964 taken along the line 99-99 in FIG. 97. FIGS. 99-104 show howdifferent rotational positions for the housing 8972 can affect the lightof the two optical sensors. As previously discussed, the housing 8972 ofthe target connector piece 8964 can have gaps 8974 a-b formed therein.In some embodiments, the light of one of the optical sensors can bescattered, reflected, refracted, or otherwise unintentionally blockedfrom reaching the corresponding light detector when an edge of one ofthe gaps 8974 a-b is positioned between the light source and lightdetector. For example, the edges of the housing 8972 at the gaps 8974a-b can have a generally rough surface that scatters light so that theedges are substantially opaque to the light from the optical sensors.

The optical sensors and the corresponding holes 8942 a-b and 8944 a-bcan be positioned such that if one light path is obstructed by one ofthe gaps 8974 a-b, the other light path will not be obstructed. Forexample, in some embodiments, the light paths can be spaced from thecenter of the target connector piece 8964 by different amounts. Forexample, a first light path can be spaced about 3 millimeters from thecenter of the target connector piece 8964 and a second light path can bespace about 1 millimeter from the center of the target connector piece8964 in the opposite direction. Other orientations are also possible.

When the housing 8972 is oriented as shown in FIG. 99, the light fromthe first light source 8976 a can travel through the target connectorpiece 8964 to the first light detector 8978 a without obstruction.Similarly, light from the second light source 8976 b can travel throughthe target connector piece 8964 to the second light detector 8978 bwithout obstruction. It will be understood that although the light canrefract as it passes through certain surfaces of the target connectorpiece 8964, the light can follow a substantially linear pathway betweenthe light sources 8976 a-b and the corresponding light detectors 8978a-b, as shown by the dotted lines in FIG. 99.

If the housing 8972 is rotated to the position shown in FIG. 100, thelight from the first light source 8976 a can strike an edge of the gap8974 b and be blocked from reaching the first light detector 8978 a.However, the light from the second light source 8976 b can pass throughthe target connector piece 8964 to the second light detectorunobstructed.

If the housing 8972 is further rotated to the position shown in FIG.101, the light from the second light source 8976 b can be obstructed byan edge of the gap 8974 a. However, in this orientation, the light fromthe first light source 8976 a can pass through the gap 8974 b withoutbeing obstructed by the edges thereof.

If the housing 8972 is further rotated to the position shown in FIG.102, the light from the first light source 8976 a can be obstructed byan edge of the gap 8974 b. However, the light from the second lightsource 8976 b can pass through the gap 8974 a without being obstructedby the edges thereof.

If the housing 8972 is further rotated to the position shown in FIG.103, the light from the second light source 8976 b is obstructed by anedge of the gap 8974 a. However, the light from the first light source8976 a can pass through the target connector piece 8964 to the firstlight detector 8978 a without being obstructed, as shown.

If the housing 8972 is further rotated to the position shown in FIG.104, the light from both light sources 8976 a-b can pass through thetarget connector portion 8964 to the corresponding light detectors 8978a-b, as shown.

In some embodiments, the target connector portion can be configured tobe used with a single optical sensor for detecting whether the valvemember is open or closed. For example, the target connector portion canbe modified so that the gaps between the walls of the housing do notintersect the light path of the optical sensor.

FIG. 105 is a side view of another example embodiment of a connector9000 which can be similar to, or the same as, the connector 8810, theconnector 3910, the connector 320, or any other suitable connectordiscussed herein. The connector 9000 can include a main body portion9002, a source connector portion 9004, and a target connector portion9006, which can be similar to, or the same as, the correspondingcomponents in, for example, the connector 8810, the connector 3910, orthe connector 320. The target connector portion 9006 can be similar tothe target connector portion 338 discussed above, and much of thedisclosure relating to the target connector portion 338 also applies tothe target connector portion 9006. FIG. 106 is a cross sectional view ofthe target connector portion 9006.

With further reference to FIGS. 105 and 106, the target connectorportion 9006 can include a housing 9008, a sealing ring 9009, a valvemember 9010, a resilient member 9012, a first end cap member 9014, and asecond end cap member 9016. The sealing ring 9009, valve member 9010,resilient member 9012, and second end cap member 9016 can be the same asthe corresponding components of the target connector portion 338. Thefirst end cap member 9014 can be a modified version of the first end capmember 405 of the target connector portion 338. The first end cap member9014 can have forward wall portion 9022 that surrounds a portion of theplunger 9024 on the second end cap member 9016 when assembled. Thehousing 9006 can include a first wall 9018 a and a second wall 9018 bwith gaps 9020 a-b formed therebetween to accommodate the elongateelastic members of the resilient member 9012.

The housing 9006 can attach to the ends of the forward wall portion 9022by sonic welding, adhesive, mechanical attachments, or any othersuitable manner. The target connector portion can be attached to acorresponding fluid transfer station that includes one or more opticalsensors so that the light path of the optical sensor passes through theforward wall portion 9022. The first end cap member 9014 can besubstantially transparent, and in some cases, the second end cap member9016 can be substantially transparent as well. For example, the lightpath can pass through the target connector portion 9006 at a locationwithin the area 9026 shown in dotted lines in FIG. 106. In some cases,the light path can pass through the target connector portion 9006 atabout the centerline through the connector (e.g., at location 9028) suchthat the light enters and exits the curved surfaces of the forward wallportion 9022 at a direction that is substantially normal to thesurfaces, thereby reducing the occurrence of unintentional redirectingof the light. Because the housing 9008 does not extend back into thelight path, the gaps 9020 a-b in the housing 9008 do not obstruct thelight. The forward wall portion 9022 can be an unbroken, generallycylindrical wall, at least in the area that intersects the light path ofthe optical sensor. Thus, a single optical sensor can be used todetermine whether the valve member 9010 is in the open or closedconfiguration.

Many different connector types can be used for the source connectorportion and/or the target connector portion of the various connectorsdisclosed herein. Various other connector types can include a valvemember, or other movable component, that can be transitioned in and outof the light path of an optical sensor to indicate whether an IV bag isattached to the connector. FIG. 107 is a perspective view of an exampleembodiment of a connector 9100. The connector 9100 can include a mainbody portion 9102, a source connector portion 9104, and a targetconnector portion 9106. The connector 9100 that can be similar to theconnector 3910 or 8810 except that the target connector portion 9106 canbe a version of the Clave® connector manufactured by ICU Medical, Inc.,of San Clemente, Calif. Various embodiments of a connector of this typeare described in the '866 patent. Additional details and alternativesare also provided in U.S. Provisional Patent Application No. 61/345,554,filed May 17, 2010, the entirety of which is hereby incorporated byreference herein.

The target connector portion 9106 can include a valve member 9108disposed therein, which can transition between a closed position when noIV bag is attached thereto and an open position when an IV bag isattached thereto.

FIG. 108 is a cross sectional view of the target connector portion 9106with the valve member 9108 in the closed configuration. FIG. 109 is across sectional view of the target connector portion 9106 with the valvemember 9108 in the open configuration.

A housing member 9110 can attach to a base 9112 to define an interiorchamber 9114 therein. The base can have a spike 9116 extending into theinterior chamber 9114 and a male end 9118 extending generally oppositethe spike 9116. A fluid pathway 9120 can run through the spike 9116 andmale end 9118. The valve member 9108 can have a head 9122 that includesa slit 9124 therein. A resiliently compressible valve body 9126 caninclude a series of accordion sections or O-rings to bias the valvemember 9108 toward the closed position. The end of the housing 9110 canbe a female luer 9130 configured to receive a male luer end 9132associated with, for example, an IV bag assembly.

In some embodiments, the housing member 9110, or at least a portionthereof, can be substantially transparent, and the valve member, or atleast a portion thereof, can be substantially opaque. Light from anoptical sensor can pass through the housing 9110 and the interiorchamber 9114 at a location 9128. When the valve member 9108 is in theclosed configuration, the light can travel through the target connectorportion 9106 substantially unobstructed, to provide a signal indicatingthat the valve member 9108 is closed and no target container isattached. When the valve member 9108 is in the open configuration, itcan be positioned in the light path such that the light is blocked fromreaching the light detector. The light detector can then provide asignal indicating that the valve member 9108 is in the openconfiguration and a target container is attached thereto.

In some embodiments, the target connector portion can include aninteraction portion. For example, in some embodiments, the interactionportion can comprise a generally opaque outer housing or can comprise agenerally transparent outer housing and an internal generally opaquemoveable portion. The optical sensor can be configured such that lightis obstructed when the valve member is in the closed configuration andthe light is permitted to pass to the light detector substantiallyunobstructed when the valve member is in the open configuration. Forexample, FIG. 110 is a cross sectional view of the target connectorportion 9106 with the light path of the optical sensor passing throughthe target connector portion 9106 at a location 9134 that is blocked bythe valve member 9108 when the valve member 9108 is closed (as shown inFIG. 110) and is substantially unobstructed when the valve member 9108is open (as shown in FIG. 111). Accordingly, the controller can beconfigured to allow fluid transfer when the light detector is able todetect light transmitted through the target connector portion 9106indicating that a source container is present, and the controller doesnot allow fluid transfer when the light detector does not detect thelight.

It will be understood that various other types of connectors can be usedfor the target connector portion 9106 and can have a location where alight path is obstructed when the connector is in a first state (e.g.,open or closed) and the light path is substantially unobstructed whenthe connector is in a second state (e.g., closed or open). Othervariations are possible. In some embodiments, the optical sensor can bepositioned to align with the connector of the IV bag assembly, or someother opaque portion of the IV bag assembly, such that when the IV bagassembly is present, the light is blocked from reaching the lightdetector to thereby generate a signal to allow fluid transfer.

Although many features of the embodiments shown in the Figures arespecifically called out and described, it will be understood thatadditional features, dimensions, proportions, relational positions ofelements, etc. shown in the drawings are intended to make up a part ofthis disclosure even when not specifically called out or described.Although forming part of the disclosure, it will also be understood thatthe specific dimensions, proportions, relational positions of elements,etc. can be varied from those shown in the illustrated embodiments.

Embodiments have been described in connection with the accompanyingdrawings. However, it should be understood that the foregoingembodiments have been described at a level of detail to allow one ofordinary skill in the art to make and use the devices, systems, etc.described herein. A wide variety of variation is possible. Components,elements, and/or steps may be altered, added, removed, or rearranged.Additionally, processing steps may be added, removed, or reordered.While certain embodiments have been explicitly described, otherembodiments will also be apparent to those of ordinary skill in the artbased on this disclosure.

Some aspects of the systems and methods described herein canadvantageously be implemented using, for example, computer software,hardware, firmware, or any combination of software, hardware, andfirmware. Software can comprise computer executable code for performingthe functions described herein. In some embodiments, computer-executablecode is executed by one or more general purpose computers. However, askilled artisan will appreciate, in light of this disclosure, that anymodule that can be implemented using software to be executed on ageneral purpose computer can also be implemented using a differentcombination of hardware, software, or firmware. For example, such amodule can be implemented completely in hardware using a combination ofintegrated circuits. Alternatively or additionally, such a module can beimplemented completely or partially using specialized computers designedto perform the particular functions described herein rather than bygeneral purpose computers.

While certain embodiments have been explicitly described, otherembodiments will become apparent to those of ordinary skill in the artbased on this disclosure. Therefore, the scope of the invention isintended to be defined by reference to the claims as ultimatelypublished in one or more publications or issued in one or more patentsand not simply with regard to the explicitly described embodiments.

The following is claimed:
 1. A method of providing a substantiallyentirely closed system for the transfer of medical fluids between oramong different medical fluid containers, the method comprising: (a)providing a fluid transfer module configured to be removably attachableto an electronically controlled fluid dispensing system, the fluidtransfer module comprising: (i) a first interface configured to beconnected in fluid communication with a fluid source container, thefirst interface comprising a first selectively openable and closeableaperture that is configured to substantially entirely prevent fluidwithin the fluid transfer module from escaping through the firstaperture when the first aperture is closed; (ii) a second interfaceconfigured to be connected in fluid communication with a fluiddestination container, the second interface comprising a secondselectively openable and closeable aperture that is configured tosubstantially entirely prevent fluid within the fluid transfer modulefrom escaping through the second aperture when the second aperture isclosed; (iii) an intermediate container or an intermediate interfaceconfigured to be connected to an intermediate container; (iv) a firstvalve configured to permit the passage of fluid from the fluid sourcecontainer to the intermediate container and configured to generallyobstruct the passage of fluid from the intermediate container to thefluid source container; and (v) a second valve configured to permit thepassage of fluid from the intermediate container to the fluiddestination container and to generally obstruct the passage of fluidfrom the fluid destination container to the intermediate container; and(b) instructing a user to attach the fluid transfer module to anelectronically controlled fluid dispensing system to assist intransferring fluid; wherein an interaction portion of the fluid transfermodule is configured to permit the electronically controlled fluiddispensing system to indicate that at least a portion of the fluidtransfer module is attached to the electronically controlled fluiddispensing system; and wherein, upon disconnection of the fluid transfermodule from the fluid source container and the fluid destinationcontainer, the fluid transfer module is configured to substantiallyprevent fluid within the fluid transfer module from escaping.